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AbbVie jobs in South San Francisco, CA

- 527 jobs
  • Senior Statistician, Research

    Abbvie, Inc. 4.7company rating

    Abbvie, Inc. job in South San Francisco, CA

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Senior Research Statistician, Statistics is responsible for providing statistical support to the research and development organization. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Senior Research Statistician works in partnership with experts in multiple disciplines to advance medicines to our patients. Responsibilities: * Contribute to design, analysis and reporting of clinical trials or other scientific research studies. Assist with development of protocols and/or statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming implementation. * Work under supervision to implement sound statistical methodology in scientific investigations. Assist in identifying scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. * Provide programming specifications for derived variables and analysis datasets. Collaborate with Data Science in preparing for database lock. With supervision perform statistical analyses as per the analysis plan. * Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines. * Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology. With supervision, develop strategy for data presentation and inference. * Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. * Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. * Work collaboratively with cross-functional teams. Clearly explain statistical concepts to non-statisticians. * Provide responses to questions and pursue analyses suggested by data under supervision. Support communications between assigned product team(s) and functional management. * Build/drive cross-functional relationships and collaboration. (SSG) Contribute to benefit-risk planning and assessment. Contribute to cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests. (SSG) Collaborate within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to better characterize the safety profile of AbbVie products, improve efficiencies, and provide greater consistency across therapeutic areas. * (GMA Stat) In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, assist with feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions. Qualifications Qualifications * MS (with 4+ years of experience) or PhD (with 0+ years of experience) in Statistics, Biostatistics, or a highly related field. * High degree of technical competence and effective communication skills, both oral and written. * Able to perform statistical computations and simulations. * Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others. * Able to build strong relationship with peers and cross-functional partners to achieve higher performance. * Highly motivated to drive innovation by raising the bar and challenging the status quo. Key Stakeholders Clinical development experts Statistical programmers Data science experts (SSG) Patient safety experts (GMA Stat) Global Medical Affairs experts Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************
    $125k-157k yearly est. 19d ago
  • Specialty Representative, Migraine - North San Francisco/Napa/Fairfield/Santa Rosa, CA

    Abbvie 4.7company rating

    Abbvie job in San Francisco, CA

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* . Job Description This role is field-based, and candidates should live within a reasonable distance from the primary city. Talent will be hired at a level commensurate with experience. Execute brand strategy and tactics in field, sales performance, effectively manage assigned territory and targeted accounts, build strong customer relationships and customer needs solving capability to maximize short and long term sales performance placing the patient into the center of any efforts and operating within AbbVie's business code of conduct, policies and all applicable laws and regulations. + Deliver sales performance, brand KPIs, financial targets, marketing objectives, etc. to meet or exceed on those objectives. + Create pre-call plan objectives and execute post-call evaluation to continuously improve sales performance. Effectively handle objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action to close on every sales call. + Proactively and continuously aspire to serve customer needs, customer expectations and challenges to build trusted customer relationships and to achieve win-win agreements between AbbVie and customers. + Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers to maximize access and sales opportunities. + Continuously build understanding on customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise and share this market intelligence information with in-field team, brand team and sales manager to achieve alignment, to anticipate environmental changes and challenges and to optimize brand strategy and its execution. + Differentiate AbbVie's value proposition with health providers assigned and identify, develop, and maintain disease state experts and speakers/advocates to maximize brand performance. Qualifications + Bachelor's degree in health, sciences, pharmacy or business-related field preferred or relevant and equivalent industry experience required + Relevant and equivalent industry experience required in lieu of a bachelor's degree is at least five (5) years of experience with three (3) or more years of experience within the pharmaceutical/health/science industry preferred and a high school diploma/GED required + Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all relevant stakeholders. Strong business acumen and proficient use of business tools; possesses strategic and critical thinking capabilities. + Proactively identifies customer style / behavior and quickly adapts to all aspects of selling approach. Understands and leverages findings to develop sales strategies. Offers innovative ideas and solutions to maximize business opportunities to address challenges. + Provides impact with ideas for the larger organization and anticipates and responds to changes. Operates effectively in a matrix environment. + Influences others and is viewed as a credible and respected role model and resource among peers. Builds collaborative partnership with district colleagues and matrix team, etc. + Leads by example; Consistently displays positive behaviors and peer coaching through changing and challenging environments. Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels. + Preferred: Proven track record of success in sales performance within respective therapeutic areas. Commercial pharmaceutical industry experiences such as physician/account-based selling, training, managed health care or marketing preferred. English language proficiency verbally and in writing (for all non-English speaking countries). + An essential requirement of your position is to satisfy all applicable health care industry representative (HCIR) credentialing requirements to gain and maintain entry into facilities and organizations that are in your assigned territory. You must also be in good standing and/or eligible to obtain these credentials + These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, proof of immunization/vaccination for various diseases, fingerprinting and specific licenses required by individual state or cities. Please remember that you are solely responsible for ensuring that you satisfy all HCIR credentialing requirements and for any associated liability for failing to do so. AbbVie has resources available to you to help answer questions you may have. + Driving a personal auto or company car or truck, or a powered piece of material handling equipment + Valid driver's license: Ability to pass a pre-employment drug screening test and meet safe driving requirements Key Stakeholders External: Specialty Physicians in Therapeutic brand area, pharmacists, nurses, others depending on brand plan. Internal: In-field team members, Sales Management (i.e. DSM), Marketing Management, Training, Customer Excellence, & Brand Plan stakeholders. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. + This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* Salary: $78,500 - $192,500
    $78.5k-192.5k yearly 27d ago
  • Director, Oncology Scientific Communications

    Pfizer 4.5company rating

    South San Francisco, CA job

    Today, Pfizer Oncology has an industry-leading portfolio of 25 approved innovative cancer medicines, including major therapies for metastatic breast cancer, prostate cancer, urothelial carcinoma, and hematologic malignancies. Pfizer's in-line portfolio is focusedon four broad, key areas: breast cancer, genitourinary cancer, hematology, and precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development. The Oncology Scientific Communications Director will report to the Team Lead within Pfizer Oncology Medical Strategy Management The Oncology Scientific Communications Director will lead the development and execution of impactful scientific communication strategies for assigned Pfizer medicines and across their tumor area, with a focus on achieving a singular scientific voice anchored tothe evidence. The Director will ensure that overall scientific communication and content strategies reflect TA priorities and that tactical execution of medical and scientific communication activities, specifically focused on optimizing the engagement and reach of emerging scientific information within the oncology community, occurs successfully and according to strategy. This role will focus on achieving a singular scientific voice anchored to the evidence, optimizing the engagement, consistency and reach of emerging scientific information within the oncology community. They will be a subject matter expert in one of the three below chosen capabilities: Therapeutic Area (TA) Scientific Communications: ensure asset strategies and messaging are seamlessly integrated into TA-specific plans and materials. The TA Sci Comms lead will also focus on the delivery of foundational resources such as Scientific Communications Platforms (SCPs), Narratives, and FAQs. Data Disclosure (Publications): Collaborate with TA teams and Sci Comms colleagues to drive the publication planning, writing, and dissemination of scientific data from clinical trials and research activities, ensuring a cohesive and impactful publication strategy across the portfolio. Medical Content: Create a wide range of engaging and informative scientific content for diverse channels and audiences, including medical to medical resources, congress and digital platform content. ROLES AND RESPONSIBILITIES The Director will be responsible for the following, with specific responsibilities varying based on the chosen Sci Comms functional focus area (TA, Data Disclosures, or Content). This role may require working across two functional areas for one product/program. General Responsibilities (applicable to all focus areas): Responsible for ensuring strategic input from a broad range of stakeholders (internal and external) is integrated into scientific communications strategic planning to meet the needs of these stakeholders and especially the Oncology Medical TA teams Support Global Product Teams, Global Medical franchises, and other Pfizer Oncology stakeholders in engaging with the external medical community on activities related to key clinical trial data readouts. Ensure alignment of each product's overall scientific content/communications strategy with relevant Pfizer Oncology stakeholders (e.g., partnering with cross-functional Medical Teams, Channel Excellence, Data Analytics, and other key stakeholders to ensure alignment of communication plans with medical priorities and optimize opportunities for broader data dissemination) Act as a strategic thought partner to the TA medical team, providing sci comms functional guidance and subject matter expertise in their designated focus area Leads financial projections and budget management for functional deliverables in addition to managing agencies and off-shore teams (if applicable) Collaborate with International Medical Channel Content team to ensure sci comms deliverables are shared with country medical colleagues for adaptation Have a thorough understanding of therapeutic area assigned, including policy related issues, and the individual inline and pipeline assets across the specific TAs with an ability either to serve as a primary point of contact for accurate, current medical and scientific knowledge or to identify the appropriate Subject Matter Expert within therapeutic area, for internal and external stakeholders and customers. Responsible for building collaborative relationships with relevant partners in and outside of Medical to ensure optimal creation and execution of channel-specific TA medical communications strategies. Stay abreast of US regulations and guidance that impact digital delivery of scientific information to external HCPs TA Communications: Accountable for strategic oversight of TA scientific communication activities and the overarching scientific communications objectives/strategy/narrative, ensuring alignment and excellence in delivery As a core member of the Global Medical Affairs Team (GMAT), responsible for identifying the need for and establishing the Scientific Communications Platform (SCP) for TA products early in development based on target profile, clinical evidence, disease state/landscape, and aspirational label. For later life-cycle assets, determine the need for and enrich the SCP (based on wide cross-functional input) with evolving evidence from clinical studies, insights, the Clinical Development Plan and regulatory strategy to ensure teams use accurate, consistent language Ensure the product-level SCP is aligned to the broader Therapeutic Area, tumor and/or modality scientific narrative and that information is pulled through to all scientific communication deliverables Establish and maintain the Scientific Communication Platform (SCP) for products in their TA, including overarching scientific communication objectives. In addition to Therapeutic Area and Asset-specific SCPs, the TA Sci Comms lead is responsible for developing global medical narratives and FAQs around key data disclosures Work closely with clinical/medical teams during data readouts to determine key messages (aligned to the SCP) Collaborate with non-Medical stakeholders (e.g. Scientific Affairs, Corporate Communication, etc.) to ensure consistency of scientific communications for non-medical audiences. Orchestrate OLT (Oncology Leadership Team) informs/reviews of key disclosures. Co-chair medical/sci-comms sub-committee(s) of the GMAT Data Disclosure (Publications): Focus: Drive and deliver on data disclosure plans, including Plain Language Summaries (PLS) and Enhanced Publication Content (EPC) Manage author reviews and preparedness Chair Scientific Publications Committees (SPCs) Work closely with clinical study teams during data readouts to determine publication content Ensure updates to global publication plans occur as needed on a regular basis Support GPTs, Global Medical franchises, and other Pfizer Oncology stakeholders by engaging with the external medical community on publication activities. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Content Focus: Lead above or specific-therapeutic area content strategies, projects, digital initiatives and broad enterprise-wide initiatives to advance content impact throughout the organization across all medical content on externally- and internally-facing medical channels Define and deliver external Global and US medical-to-medical content for Field/HQ/Congresses; congress content, digital medical platforms, and content for newly prioritized medical channels. Ensure updates to global congress content occurs as needed on a regular basis in coordination with key cross-functional stakeholders, including commercial, development and Medical TA teams and platforms. Responsible for ensuring the creation of field medical content is aligned with the needs of the Pfizer Oncology Global Medical TA team and regional/local Medical Affairs. Proactively resolve issues around content creation, combining medical affairs expertise with an understanding of the patient, healthcare professional, legal, regulatory, and organized customer points of view. Define and deliver TA training content with support from Platform training teams when applicable. Serve as a core member of medical/sci-comms sub-committee(s) of the GMAT. Note: while colleagues will typically focus on one of these areas, there is an expectation that if a business need arises, the team member can adapt and support other functional focus areas. QUALIFICATIONS Bachelor's degree with a minimum of 10 years of relevant biopharmaceutical/biotech or agency experience (such as Medical Communications, Medical Affairs or scientific communications within Clinical Development roles). Advanced scientific degree (PhD, PharmD, MS, etc.) preferred Experience developing strategic scientific communications and other scientific content to support scientific exchange, including the use of tools and programs to meet the needs of HCPs. Have a strong understanding of Medical Affairs, including medical strategies, disease areas, and objectives. Ability to quickly build rapport and credibility with key internal and key external stakeholders through strong interpersonal skills; strong matrix leadership Demonstrated ability to translate complex scientific concepts and data into meaningful and digestible communications and foundational tools that can be utilized via multiple channels including at scientific conferences. Strong track record of written and oral communication skills to develop and present scientific information to varied audiences and articulate messages succinctly. Strong organizational skills to track numerous tasks for multiple simultaneous projects in a deadline-oriented environment. Experience working in a highly regulated environment and delivering scientific content in a compliant yet innovative manner, leveraging the latest technologies to ease the consumption of critical scientific information. Experience with omnichannel, including diverse content development - such as publications, plain language summaries, Congress materials, publication extenders, podcasts, and short-form articles for 3rd party digital platforms. Experience with scientific peer-reviewed publications. PREFERRED QUALIFICATIONS Oncology experience strongly preferred. Advanced medical/scientific degree (MS, PhD, PharmD), with 8+ years' experience (if Masters) or 6+ years' experience (if PhD or PharmD) NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel 15-20% #LI-PFE Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. The annual base salary for this position ranges from $169,700.00 to $282,900.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.* The annual base salary for this position in Tampa, FL ranges from $152,700.00 to $254,500.00. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ...@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical
    $169.7k-282.9k yearly 1d ago
  • Oncology Late Stage Clinical Scientist (Senior Manager, Non MD)

    Pfizer 4.5company rating

    South San Francisco, CA job

    You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio. KEY RESPONSIBILITIES Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate . Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams , governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s , analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings , seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure. MINIMUM QUALIFICATIONS PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval. Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance. Experience working on large data sets. Proficiency with Microsoft Office and relevant scientific software Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery. Experience leveraging a variety of communication tools and techniques to communicate results Experience solving problems collaboratively and handling conflict constructively. Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. Experience working proactively and independently, organizing tasks, time and priorities of self and others. Experience building partnerships across the company to achieve the needs of the program. PREFERRED QUALIFICATIONS Experience in Hematology Oncology COMPETENCIES FOR SUCCESS Demonstrates passion for helping patients with cancer and for the science of oncology. Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned. Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities. Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes. Leverages knowledge and support from others related to overall objectives , strategy, critical issues, and policies. Demonstrates foresight and judgment to make complex decisions Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes. Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Has a global perspective and mindset. Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies . both as a leader and a key contributor Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: This is a Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week. The annual base salary for this position ranges from $135,100.00 to $225,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical
    $135.1k-225.1k yearly 3h ago
  • Senior Oncology Account Specialist Hematology San Francisco, CA

    Pfizer 4.5company rating

    Palo Alto, CA job

    Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. The Senior Oncology Account Specialist (SOAS) will have a variety of responsibilities, ranging from promoting Pfizer's product portfolio to health care providers and specialists, to educating members of the healthcare community regarding the appropriate use of Pfizer products, to calling on accounts and organized customers to help improve patients' experience with Pfizer products, as well as the overall quality of patient care delivered. The SOAS plays a critical role in increasing Pfizer's brand with high-value target customers by linking an insightful assessment of the account and/or business landscape with a strong understanding of Pfizer's products and resources. BASIC QUALIFICATIONS BA/BS Degree from an accredited institution BA/BS Degree from an accredited institution OR an associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) with 10+ years of relevant experience. Ability to travel domestically and stay overnight as necessary Valid US driver's license and driving record in compliance with company standards. Any DUI/DWI or other impaired driving citation within the past 7 years will disqualify you from being hired Minimum of 4 years of previous Pharmaceutical Sales experience or minimum of 4 years of previous Oncology Healthcare Professional (HCP) experience working with key Oncology thought leaders or high influence customers in hospitals, large group practices or managed care organizations. A demonstrated track record of success and accomplishment with previous Pharmaceutical Sales experience or Healthcare Professional (HCP) experience Exceptional aptitude for learning and ability to communicate technical and scientific product and disease management information to a wide range of customers Demonstrated high degree of business acumen Proficiency using complex digital applications and able to adapt to Pfizer's long-range technology model in bringing relevant Pfizer information to market. PREFERRED QUALIFICATIONS 3-5 years of Oncology sales experience Master's Degree Advanced Healthcare Professional (HCP) Degree Experience calling on institutions, NCI centers and Key Opinion Leaders Functional / Technical Skills can include: Promote broad portfolio of products; Strong knowledge of disease states, therapeutic areas, and products Deep knowledge of applicable customers and markets (prescribers/HCPs/institutions/ organizations) Generate demand for Pfizer products in assigned accounts Strategic account selling and management skills. Develop comprehensive territory/account/customer plans to drive achievement of desired objectives. Maintain relationships throughout institutions Overcome obstacles to gain access to difficult to see health care providers and customers. Cultivate relationships with KOLs; build lasting relationships with top priority customers Assess needs of target physicians/accounts; Address needs with responsive approach, targeted skills, and appropriate resources Superior selling, technical and relationship building skills Demonstrated ability to engage, influence and support customers throughout the selling process; excellent communication and interpersonal and leadership skills. Demonstrated ability to quickly learn and embrace new ways of working in a rapidly changing environment. Possess the ability to work in a matrix environment and to leverage multiple resources to meet customer needs and deliver results. Other Job Details Territory includes but not limited to: San Francisco CA and south including east Bay Relocation might me offered The annual base salary for this position ranges from $101,500 - $245,400. During initial new hire sales training, you will be classified as a salary non-exempt employee which entitles you to overtime pay. Upon your training certification, you will become an overtime exempt employee. In addition, this position offers an additional Sales Incentive bonus. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits| (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email ...@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Sales
    $80k-109k yearly est. 5d ago
  • Sr. Operation Associate - Warehouse

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Responsibilities The Sr. Associate - OA Warehouse is responsible for daily performance management and support of the process team. This individual must ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the Warehouse Process Team. The individual will be taking leadership role for the area process team, managing process improvements for the area, acting as a liaison between Warehouse Operations and multiple support groups in execution of improvements, change controls, quality / HSE event management. In addition, the role will provide leadership coverage in the absence of the Manager. Key Objectives/Deliverables: * Responsible for the Warehouse and Logistics roadmap: developing and creating the roadmap, defining action plans, initiating change management documentation and tracking progress to ensure successful execution. * Provide leadership on manufacturing floor ensuring high levels of safety, quality, and productivity to maintain reliable supply of products to patients. * Lead the deviation process for the warehouse operations in collaboration with other functions. * Lead/conduct area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups * Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations. * Participating in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE). * Define, monitor and propose solutions to improve or meet meaningful Key Performance Indicators (KPI) for the Warehouse Process Team to drive performance. * Understand and influence the Material control strategy for the site. * Provide operational and project support for the business responsibilities within Concord Warehouse Operations. * Provide analysis of specific operational or business processes as identified by management. * Manage warehouse capacity; propose and implement projects, as required. * Present warehouse processes, investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. * Lead area tours to support business reviews, regulatory audits, or network collaboration. Basic Qualifications * Bachelor's degree (or equivalent work experience). Additional Skills/ Preferences * Experience in areas of materials management, logistics, warehousing, and distribution. * Experience in manufacturing operations and/or manufacturing support functions. * Knowledge of GMP requirements. * Strong interpersonal, communication, problem-solving and analytical skills * APICS CPIM certification is a plus. * Career interests in operations or supply chain leadership. Additional Information * Must be flexible to attend meetings or support off-shifts as necessary. * On call support can be required as needed to support business needs Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $58,500 - $137,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $58.5k-137.5k yearly Auto-Apply 1d ago
  • Operator, Formulation (Night Shift)

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Job Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. Job Responsibility As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements * We have several levels open for Operator which are based on the experience and education you bring. * Minimum education: High School Diploma or GED * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * A valid driver's license. * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity Time Commitments and Work Authorization * Ability to work 6pm to 6am on a 2-2-3 schedule * Must Pass a "fitness for duty" physical exam * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Experience with, completion of, or understanding of: * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Formulation, dispensing, material preparation. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $79k-105k yearly est. Auto-Apply 27d ago
  • Operator, Aseptic Filling (Night Shift)

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Position Description Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection. They will become the experts within their assigned area and educate their team in the proper operation of the facility. After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Operators will support daily activities to meet capacity plans while developing their own and our team's capabilities. As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles. Key Values / Objectives Integrity * Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor. * Responsible for administering technical training and ensuring all operators are trained to perform tasks. * Operate the equipment and perform activities as required to meet production schedule. * Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs) * Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Respect for People * Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas. * Key liaison between operations and support functions. Basic Qualifications/Requirements: Time Commitments and Work Authorization * Minimum education: High School Diploma or GED * A valid drivers license * Must Pass a "fitness for duty" physical exam * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. * Must pass a vision exam and be free of color blindness * Must be equivalent to 20/20 correctable close vision acuity * Must be able to work a 2-2-3 schedule Additional skills/preferences: Experience with, completion of, or understanding of: * We have several levels open for Operator which are based on the experience and education you bring. * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * Ability to participate in professional development opportunities (team coursework such as classes through RCCC) * Ability to effectively communicate (electronically, written and verbal) * Flexibility - the ability to troubleshoot and triage challenges * Computer proficiency (desktop software, MS office). * Leadership and the ability to train / educate team members * STEM degree or certifications * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Knowledge of current Good Manufacturing Practices (CGMPs) * Experience in operations or manufacturing environments. * Pharmaceutical, medical device or food processing industries * Manufacturing Execution Systems and electronic batch release. * Continuous improvement (Lean, Six Sigma methodologies) * Highly automated equipment (inspection, packaging, filling, assembly, etc) * SAP, Electronic Batch Records Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $38k-44k yearly est. Auto-Apply 58d ago
  • ExploR&D Clinical Program Lead

    Eli Lilly and Company 4.6company rating

    San Francisco, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Overview Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLabs-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning. Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support-from strategic consulting to full program execution-making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines. Job Summary The ExploR&D Program Lead (EPL) serves as the single point of accountability for external collaboration projects within Lilly's ExploR&D organization. The role focuses on defining strategy, developing aggressive timelines and budgets, and leading cross-functional teams from Catalyze360 and Lilly Research Laboratories to deliver high-quality results on time and on budget. Reporting within the Catalyze-360 Project Management structure, the EPL leads diverse, cross-functional teams to deliver innovation by pioneering novel science and technologies that advance future medicines and transform R&D collaboration models. Key Responsibilities Team Leadership and Project Management Lead multiple collaboration teams comprised of ExploR&D personnel, LRL subject matter experts and external biotech collaborators. Create a high-performing team with a culture of trust, autonomy, agency, collaboration, and inclusion. Deliver projects ‘on time, on budget', and within scope from discovery/pre-clinical development through clinical proof-of-concept using contemporary project management tools and approaches. Scientific and Technical Leadership Identify and synthesize relevant, technical information from a variety of sources including scientific literature, internal and external subject matter experts, and experimental or trial data to address key questions and guide study design and program strategy. Provide and critically evaluate content within critical documents (e.g., Investigator Brochures, Risk Profiles, Study Protocols, Study Reports, Regulatory and Ethical filings and updates, Investigator updates, etc.). Serve as the ExploR&D scientific leader responsible for rationale, integration of cross-functional data, synthesis of the risk/benefit profile, strategic conclusions, and designs to drive data-driven decision making. Collaboration and Relationship Management: Serve as primary liaison between Lilly and external biotech collaborators, fostering strong relationships, transparent communication and ensuring alignment on project goals. Anticipate and resolve barriers to success by identifying potential roadblocks early, offering innovative solutions, and ensuring that collaboration programs are executed with excellence. Create a ‘partner of choice' experience accounting for partner's goals and priorities, optimizing strategic plans with the spirit of an entrepreneurial drug developer to enable stakeholder decision-making and value-creation. Operational Excellence and Process Improvement: Contribute to diligence and workplan development that optimize outcomes for Lilly and external collaborators. Drive operational excellence in program management by identifying and implementing process improvements that enhance the efficiency and effectiveness of external collaborations. Basic Qualifications/Requirements Education: Advanced graduate degree (PhD, PharmD, or Masters) in a health-related, scientific or engineering field Experience: 10+ years of work experience in the pharmaceutical industry including preclinical-translational sciences and/or clinical drug development across therapeutic modalities such as cell and gene, antibodies, peptides, oligonucleotides, vaccines, and small molecules. Additional Skills/Preferences Fluent Mandarin speaking and writing skills. Prior experience managing external collaborations with proven track record of overseeing complex, cross-functional and external partnering projects. Demonstrated ability to lead and influence teams in a matrixed environment, driving collaboration across diverse functions and geographies. Exceptional verbal and written communication skills, with ability to clearly articulate project goals, strategies, and results to both internal and external stakeholders. Demonstrated ability to anticipate challenges, diagnose root causes, and implement creative solutions that drive project success. Strong intuition for business, with a deep understanding of asset strategy, portfolio management, and the broader pharmaceutical landscape. Practical experience or certification in project management. Intellectual agility to quickly adapt to changing circumstances, learn from past experiences, and apply learnings to new situations. Strong ability to think with a portfolio-level mentality, ensuring that individual program decisions align with the overall goals of ExploR&D and Catalyze360. Additional Information Location: San Francisco, CA Travel up to 25% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $187,500 - $275,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $187.5k-275k yearly Auto-Apply 19d ago
  • Maintenance Technician - Night Shift

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Quick Benefits Overview: * Medical, Dental, Vision, Prescription benefits are effective on your first day of employment * Paid vacation- starting annually at 120 hours (prorated based on start date) * Shift Bonus for Weekend hours * Sign-on bonus For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Responsibilities: The focus of the Maintenance Technician - Night Shift is to provide maintenance expertise to service, repair, and maintain process and utility other pharmaceutical manufacturing equipment currently in service. The Maintenance Technician - Night Shift is expected to understand the needs and requirements of the customer (Operations); must be able to work effectively with customers, handle customer questions with tact and understanding while displaying good customer service. Key Objectives/Deliverables: * This role is expected to improve equipment uptime, line efficiency, and increase overall equipment effectiveness in a production environment by condition monitoring, troubleshooting, and assisting in engineering changes. * Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations. * Must be willing to work with safety as a primary focus and abide by applicable safety procedures and practices. * Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance). * Perform repairs and overhaul equipment (e.g., gear boxes, pumps, blowers, fans and drives) to include disassembly, setting tolerances, aligning, resetting timing (e.g., air compressors, vacuum pumps) * Setup equipment to design specifications (e.g., timing, leveling, alignment) * Operate precision alignment equipment (e.g., Roma-align, lasers, etc.) * Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime. * Must accurately document the actions taken to repair the equipment in the CMMS program. * Willing to assist in areas outside of their primary responsibility and learn other skills, as required Basic Qualifications: * High school diploma/GED * Minimum 2 Years of Maintenance * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position * Must satisfy background check and drug screening requirements. Additional Skills/Preferences: * Must be able to speak, read and write English at a sufficient level to communicate technical and business information effectively. * Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite and other required software programs. * Must be able to effectively work in a team environment. * Physical considerations include the ability to work with or around equipment, climb ladders and stairs and use PPE (Personal Protective Equipment). He/she may be exposed to harsh weather conditions as part of the job. * Good, all-around hands-on experience with repair of equipment. * Use basic trouble shooting equipment such as multi-meters, calipers ect. Additional Information: * Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads. * The Maintenance Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position. * Night shift role. Will transition to a night shift 12-hr 2-2-3 schedule in the future. For the training period, it will be a day shift role. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $21.27 - $46.88 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $71k-101k yearly est. Auto-Apply 60d+ ago
  • Director, Parenteral Sterility Assurance

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $133.5k-220k yearly Auto-Apply 27d ago
  • Automation Technician - Night Shift

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss! Responsibilities: The Automation Technician - Night Shift is responsible for equipment performance, providing first-line support to production processes, as well as supporting area engineering initiatives, process improvements, project implementation, performing mechanical repairs and adjustments, and executing routine PMs. This position will require the development of expertise in production processes, commissioning, qualification, and validation requirements and equipment-specific code and/or control system technologies. The Automation Technician - Night Shift will help ensure that equipment is maintained in a qualified state, can be operated safely, and maintenance is properly performed on the systems. Key Objectives/Deliverables: * Assure that operational and maintenance procedures and practices reflect safety concerns. * Perform activities in accordance with cGMPs and applicable procedures. * Must possess a good mechanical aptitude to troubleshoot and repair equipment while, following departmental rules and regulations. * Troubleshoot the root causes of machine problems (e.g., excessive vibration or temperature, bearing failures, abnormal noises, and poor performance). * Identify opportunities to improve quality using equipment performance data and by assuring maintenance is performed appropriately. * Setup equipment to design specifications (e.g., timing, leveling, alignment) * Operate precision alignment equipment (e.g., Roma-align, lasers, etc.) * Must have the ability to quickly and accurately diagnose the root cause of a problem and implement the proper corrective actions to minimize downtime. * Must accurately document the actions taken to repair the equipment in the CMMS program. * Willing to assist in areas outside of their primary responsibility and learn other skills, as required * Experience in instrumentation, PLC and/or HMI programming. * Effectively communicate with all levels to ensure all projects and repairs are well planned and coordinated with minimal disruption to that area involved. * Working with the process team, including engineers and operations personnel, participating in and sometimes leading the development of equipment design, procedures, engineering studies, and maintenance practices that will enable the process to operate as required. * Seek out and identify opportunities to improve equipment operational effectiveness and reliability. * Must be able to effectively use business software programs, such as, Maximo, Microsoft Outlook, Microsoft Office Suite etc. * Provide technical support to engineering in: * Investigating and resolving issues that create production delays * Transferring knowledge of equipment capabilities and operational techniques to operators, engineering, and maintenance. * Implementing tools for operations and engineering to learn and work more proficiently. * Create maintenance action plans as needed to support maintenance and troubleshooting activities. * Participate in periodic reviews of equipment state. * Plan and execute small projects for process or equipment improvements or changes. Minimum Requirements: * High school diploma/GED * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position * Must satisfy background check and drug screening requirements. Additional Preferences: * Demonstrated ability to work safely in a participative environment. * Experience in a GMP manufacturing environment. * Studio 5000 and Factory talk view SE programming experience. * Demonstrated proficiency with Microsoft Word and Excel; proficient at typing and writing technical documents. * Demonstrated ability to work independently with strong organizational skills and attention to detail and ability to adapt to rapidly changing priorities * Demonstrated strong interpersonal skills and communications skills with a customer service attitude. * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. * Previous experience with highly automated equipment * Experience with B&R platform is a plus. * Knowledge of Parenteral / Packaging equipment and manufacturing operations * Experience with Maximo or similar computerized maintenance management system. Other Information: * Overtime may be required during shutdowns, emergency situations, or periods of heavy workloads. * The Automation Technician - Night Shift will work in and around potentially dangerous and hazardous equipment, powders, liquids and gases. Safety is paramount for this position. * Day Shift role currently. Will transition to a Night Shift 12-hr 2-2-3 schedule in the future. This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $21.27 - $46.88 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $21.27 - $41.25 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $63k-80k yearly est. Auto-Apply 47d ago
  • Head of Solid Tumors, Global Medical Affairs Oncology

    Abbvie 4.7company rating

    Abbvie job in San Francisco, CA

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description The Head of Oncology Solid Tumors Medical Affairs, will be responsible for leading and overseeing the Global medical affairs strategy, execution, and scientific leadership for the oncology solid tumor portfolio. This role requires expertise in oncology drug development, clinical trials, regulatory interactions, and cross-functional collaboration. The Head will serve as the key medical leader for solid tumor assets, ensuring that scientific data is translated effectively to enhance patient care and meet company goals. The role will involve close collaboration with clinical development, commercial, regulatory affairs, and market access teams to ensure alignment of the medical strategy with broader business objectives. Responsibilities : Leadership and Strategy: Lead the development and execution of the global medical affairs strategy for the oncology solid tumor portfolio, including pipeline products and marketed therapies. Provide strategic direction to the oncology medical affairs team, ensuring alignment with overall business and corporate goals. Collaborate with senior leadership to define and implement the long-term vision and strategy for oncology solid tumors within the company. Scientific Expertise and Communication: Provide deep scientific leadership in oncology solid tumors, including the interpretation and communication of clinical data, emerging scientific trends, and new therapeutic approaches. Serve as the scientific face of the company in external engagements with key opinion leaders (KOLs), healthcare professionals, academic institutions, and patient advocacy groups. Ensure the effective dissemination of scientific information through publications, congress presentations, advisory boards, and medical education activities. Cross-Functional Collaboration: Work closely with the clinical development Leaders to ensure alignment of clinical trial design, execution, and data interpretation with medical affairs objectives. Collaborate with regulatory affairs to support regulatory submissions and interactions with health authorities, ensuring that medical perspectives are integrated into regulatory strategies. Partner with commercial and market access teams to ensure the scientific and clinical perspectives are integrated into marketing strategies, product positioning, and market access strategies. Medical Affairs Operations: Lead the execution of key medical affairs activities, including evidence generation through medical affairs studies, external scientific engagements, and medical education initiatives. Oversee the generation of scientific publications, abstracts, and posters to ensure the timely dissemination of data from clinical trials and real-world evidence. Ensure that all medical affairs activities comply with regulatory, legal, and ethical standards. Team Leadership and Development: Lead and mentor the oncology solid tumors medical affairs team, fostering a high-performance culture and ensuring the team has the resources, skills, and training necessary to succeed. Drive professional development initiatives for team members to enhance their scientific expertise, leadership capabilities, and operational efficiency. Establish clear performance expectations, conduct regular evaluations, and provide feedback and coaching to enhance team effectiveness. External Engagement: Build and maintain strong, long-term relationships with KOLs, clinical investigators, and external partners in the oncology solid tumor space. Represent the company at key scientific conferences, industry events, and forums to present and discuss clinical data, treatment innovations, and the company's vision for solid tumor therapies. Engage in strategic partnerships and collaborations with academic institutions, research organizations, and other stakeholders to enhance the company's scientific reputation. Qualifications M.D., or equivalent advanced degree in a relevant scientific discipline (e.g., oncology/hematology). 15+ years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology, specifically clinical Oncology (Solid Tumors). Demonstrated expertise in clinical development, regulatory requirements, and commercialization of oncology therapies. Proven leadership experience in medical affairs, including managing cross-functional teams and influencing strategic direction at the senior executive level. Strong scientific knowledge of solid tumor biology, clinical trial design, biomarker development, and emerging treatment modalities (e.g., immuno-oncology, targeted therapies, precision medicine). Proven ability to Lead cross-functionally and collaborate effectively with clinical development, regulatory, commercial, and other business functions. Exceptional communication skills, with experience presenting complex scientific information to both technical and non-technical stakeholders. Preferred Skills: Experience with Solid tumors therapies in key areas such as NSCLC, CRC, GyN tumors and others. Familiarity with advanced cancer treatment modalities such as ADCs therapies, combination therapies, and immuno-oncology. Strong publication and scientific communication track record in oncology, including contributions to peer-reviewed journals and major oncology conferences. Experience in managing global medical affairs activities across multiple geographic regions (focus on Global strategy and US region). Physical Requirements: Ability to travel domestically and internationally (up to 25-30%). Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $103k-130k yearly est. 3h ago
  • Associate - QA Batch Disposition

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss! Job Responsibilities: The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The QA Batch Disposition is responsible for final disposition of Semi-Finished and/or Finished drug combination products. The QA position is essential for ensuring GMP compliance in the qualification, validation, control strategy and startup of operations to ensure regulatory approval of the facility. Electronic batch records with high integration and focus on data integrity will be utilized to confirm manufacturing production. * Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems * Performs final batch disposition of semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner * Effectively own/review/approve GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls) * Additional job duties as required Basic Requirements: * Bachelor's degree in STEM * Experience working in the pharmaceutical or medical device industry in QA roles * Previous batch disposition experience * Ability to make technical decisions, provide guidance to the site * Proficiency with applicable computer systems * Demonstrated strong oral and written communication skills * Demonstrated interpersonal skills and the ability to work as a team * Root cause analysis/troubleshooting skills * Demonstrated attention to detail and ability to maintain quality systems * Previous regulatory inspection readiness and inspection execution experience * Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R4. Additional Skills/Preferences: * Ability to work 8-hour days - Wednesday through Sunday Day Shift (not eligible for remote work) * Ability to work overtime and be on-call as required * Proven ability to work independently or as part of a Team to resolve an issue * Previous experience with Event and Change Management process * Proficiency with SAP, MES, and Trackwise * Previous experience with device and parenteral product materials Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $65.3k-169.4k yearly Auto-Apply 20d ago
  • Supervisor - Parenteral Operations - Formulation (Days)

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People Position Overview Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site. If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity! During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-9 month short term assignments) with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently. Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators. As a site leader and expert at our growing site, there will be significant opportunities for growth into future leadership and technical roles. Key Responsibilities Integrity * Leading by examples with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. * Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals. * Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques. Excellence * Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts. * Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence. * Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value. * Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence. * Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation. * Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality. Respect for People * Support the site in building a diverse, empowered, and capable team. * Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift. * Responsible for the coaching, development, and performance evaluation of operators. * Communicate cross functionally with support team if there are quality, equipment, operational concerns. Requirements (Education, Experience, Training) Education, Experience and Skills * High School Diploma or equivalent * Prior supervisory experience * Basic computer skills (desktop software, MS Office) are required. * Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable). * Excellent interpersonal, written, and oral communication skills * Strong organizational skills and ability to handle and prioritize multiple requests. * Strong technical aptitude and ability to train and mentor others. Time Commitments and Work Authorization * Ability to work overtime as required * Ability to wear safety equipment (glasses, shoes, gloves, etc) * Ability to work and gown in a cleanroom (Grade C, ISO 8) environment. * The position may require a short term assignment of 3, 6, or 9 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory. * Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Preferred attributes but not required Experience with, completion of, or understanding of: * 4+ years in manufacturing/operations with 2+ years in supervisory role * cGMP standards and FDA (or other industry) guidelines for production * STEM degree or certification * Aseptic filling, single use assemblies, isolator technology. * Automated, semi-automated, and/or manual inspection. * Highly automated equipment (inspection, packaging, filling, assembly, etc.) * Manufacturing Execution Systems and SAP or other electronic business systems * Continuous improvement methodologies and mindset - lean, six sigma, etc. * Root cause analysis and implementing corrective actions * Ability to organize and motivate teams * Facility, Equipment, Systems, Start-up Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $35.33 - $57.12 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $107k-133k yearly est. Auto-Apply 26d ago
  • Director - Immunology Research

    Eli Lilly and Company 4.6company rating

    San Francisco, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. We are a leading biopharma company dedicated to advancing therapies that extend healthspan and combat age-related diseases. We are seeking a highly motivated scientist to join our research team to spearhead efforts focused on immune aging and rejuvenation. In this role, you will drive cutting-edge research to identify and develop novel interventions, using any modality that is appropriate for the indication, to restore immune homeostasis, mitigate inflammaging and improve organ function. This position offers the opportunity to pioneer transformative therapies to ameliorate prevalent and debilitating conditions in the aging population, with a focus grounded in Immunology. The individual will have the opportunity to build and manage a research team supporting immune-aging projects and to provide cross-functional leadership through larger collaborative efforts. Responsibilities • Design and execute preclinical studies to investigate mechanisms underlying immune senescence, including but not limited to age-related hematopoietic stem cell (HSC) dysfunction, telomere attrition, senescence-associated phenotypes, and T-cell exhaustion. • Develop rejuvenation/reprogramming strategies to revitalize hemopoietic and non-immune, parenchymal cells of interest in immune and age-related disorders. • Utilize advanced techniques in cytometry, ‘omics and hi-dimensional datasets to identify targetable nodes for intervention. Use appropriate in vitro, in vivo and ex vivo models to assess immune aging phenotypes of interest. • Collaborate with stakeholders in Immunology and other therapeutic areas to cross-functionally lead and develop research findings into future clinical candidates. • Prepare and present research findings at internal meetings, scientific conferences, and in peer-reviewed publications. • Stay abreast of emerging advances in the field to inform strategic decisions and help assess external opportunities as needed. • Contribute to IP filings, and regulatory documentation as needed. • Recruit and train a small team to scale research efforts. Basic Qualifications/Requirements: • PhD in Immunology, Cell Biology, Developmental Biology, or a related field; Postdoctoral experience in aging biology or rejuvenation is required. • 5+ years of hands-on research experience in academia, biotech, or pharma, with a proven track record related to immune aging/senescence research. Additional Skills/Preferences: • Demonstrated expertise in molecular mechanisms of immune senescence, including inflammaging, stem cell exhaustion, and therapeutic interventions • Familiarity with landscape of immune aging research activities including but not limited to academic labs, biotechnology companies, and large pharma. • Strong publication record in high-impact journals with first- or senior-author contributions. • Proficiency in experimental design, data analysis and statistical methods. • Excellent communication skills, with the ability to convey complex scientific concepts to diverse audiences. • Experience with in vivo models of aging (e.g., progeroid mice, humanized models) and translational strategies for rejuvenation therapies. • Advanced knowledge of stem cell rejuvenation techniques, epigenetic reprogramming and delivery systems. • Prior experience leading a cross-functional team and/or managing others. • Understanding of the unique regulatory hurdles in regeneration and aging-related therapeutics. Additional Information: Travel: Estimated ~20% Work Environment: Position is based in South San Francisco, CA Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $281,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $163.5k-281.6k yearly Auto-Apply 53d ago
  • TS/MS Engineer - Cleaning Validation/Sterilization Validation

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation/Sterilization Validation - Technical Services / Manufacturing Science (TS/MS) role is a technical position that develops and supports the validation of production equipment and systems and provides technical leadership regarding temperature mapping, cleaning and sterilization validation strategies. Primary objectives include the start-up and compliant manufacturing of products, particularly as it relates to development and implementation of validation strategies, including sterilization validation, cleaning validation, filter validation, and other related activities. The scope of the role includes device assembly, packaging, and syringe filling operations for commercially manufactured products targeted for transfer to the Concord site. Key Objectives / Deliverables: * Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. * Provide technical support for all start-up activities related to temperature mapping, cleaning and sterilization programs. * Development and execution of cleaning and sterilization strategies that focus on the validation of production equipment and systems (e.g., tanks, component/parts washer, autoclaves, filling isolators, etc). * Support periodic requalification activities for production equipment and systems. * Author and support the execution of validation protocols and reports. * Provide technical guidance to the Process Team for cleaning and sterilization processes. * Lead or provide technical support for root cause investigations related to cleaning, sterilization, and other related activities. * Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. * Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of cleaning and sterilization processes. * Participate or provide guidance for equipment cleaning and sterilization programs during internal and external audits, including regulatory inspections, as needed. * Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc. * Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda. * Serve as cleaning and sterilization interface external to the Concord site. * Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives. * Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain. * Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities. Minimum Requirements: * BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline * 3+ years experience supporting cGMP manufacturing (specifically within validation, engineering, technical services/MSAT, operations, quality assurance, etc.) Additional Preferences: * In depth knowledge of parenteral drug product manufacturing * Experience executing equipment qualification, cleaning validation, and sterilization validation * Demonstrated successful leadership of cross-functional teams * Experience with data trending and analysis * Ability to analyze complex data and solve problems Other Information: * Role is Monday through Friday based. * Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). * Occasional extended hour and / or off-hour work may be required. * Position will be based out of Concord site with ability to travel to Indianapolis and other global Lilly sites as required Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $66k-171.6k yearly Auto-Apply 47d ago
  • Principal Process Engineer

    Eli Lilly and Company 4.6company rating

    Concord, CA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. * Responsibilities The Senior Principal Process Engineer provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process engineers, developing and sustaining process knowledge, process and equipment support, process optimization, equipment qualification, equipment capability and asset management, and engineering business systems. This role will support production operation in small molecule or peptides manufacturing. Key Deliverables: * Coach and mentor front line process engineers in all aspects of fundamental engineering activities for batch API supply or continuous platforms. * Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions based on first principles. * Support and peer review root cause analysis for equipment and operational events and other technical documents. * Identify process knowledge gaps that impact equipment and process capability. * Develop or support the capture of key process knowledge (material and energy balances, kinetics, chemistry, equipment design basis, etc). * Support, develop and maintain the basis of safety for process equipment. * Provide engineering support for Process Safety Management (PSM) and Process Hazard Reviews (PHRs). * Review the basis for the qualification of the equipment and ensure that the equipment/system is appropriate for the intended purpose. * Ensure that changes, maintenance and other interventions do not adversely impact the qualification state of the equipment. * Integrate mechanistic modelling, process simulation and analysis into current and future processes to enhance process understanding and control. * Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team. * Lead/support the tech transfer of new processes and unit operations across batch and continuous processing platforms. * Provide technical oversight of ongoing equipment qualification requirements. * Provide technical oversight during development of equipment and process system User Requirements and related Design Review/Qualification documentation to ensure equipment and systems are appropriate for intended purpose. * Provide guidance in development of test plans for Verification packages and associated critical components. * Provide guidance on key elements of return to service requirements for equipment after interventions such as maintenance. Basic Qualifications * Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline * 5+ years of experience in API Manufacturing Unit Operations Additional Skills/Preferences * Deep technical interest and understanding in the field of Chemical Engineering. * Strong analytical and problem-solving skills. * Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals. * Ability to coach others for development of technical knowledge and skills. * Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented. * Guidance/mentoring of others through processes. * Flexibility to meet business needs. Additional Information: * Please note that the role may begin remotely with occasional business travel to the Global Headquarters in Indianapolis, Indiana and to the new site area. Full relocation to the area of new site will be required. Additional information will be provided during the interview process. * Potential for travel (less than 20% - could be domestic and/or international) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $94,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $64.5k-94.6k yearly Auto-Apply 1d ago
  • Scientist - Target Discovery & Biology

    Amgen 4.8company rating

    South San Francisco, CA job

    Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientist - Target Discovery & Biology What you will do Let's do this. Let's change the world. In this vital role you will join the Target Discovery & Biology team in South San Francisco. This role will use functional genomics approaches to advance target discovery, validation, and progression across therapeutic areas and modalities. Key Responsibilities: Use creativity and meticulous experimentation to design, optimize and execute functional genomics projects to discover novel therapeutic targets and answer key biological questions Lead and support projects from inception through target identification, validation and mechanism-of-action studies Collaborate across diverse functions and teams to drive impactful outcomes Communicate findings with internal teams/stakeholders as well as in conferences and peer-reviewed publications What we expect of you We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Scientist with these qualifications. Basic Qualifications: Doctorate degree or Master's degree and 2 years of relevant scientific experience or Bachelor's degree and 4 years of relevant scientific experience Preferred Qualifications: Track record of scientific productivity and innovation as demonstrated through career experiences, project outcomes and/or publications Track record of taking on new areas of research and biology with successful outcomes Demonstrated ability to work collaboratively in cross-functional teams Strong experience across the range of techniques relevant to cell biological studies (including cell culture & engineering, molecular biology, imaging and cytometry) Experience in executing large scale and/or complex screens (such as pooled or arrayed with genetic/chemical perturbations) and follow up validation studies Additional experience relevant to applying functional genomics approaches to new target discovery across diverse indications What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance. Salary Range 129,926.00 USD - 154,420.00 USD
    $95k-133k yearly est. Auto-Apply 57d ago
  • 2026 BioCMC Intern - Developmental Sciences (PhD)

    Abbvie 4.7company rating

    Abbvie job in South San Francisco, CA

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ************** . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description BioCMC Developmental Sciences Intern Overview Envision spending your summer working with energetic colleagues and inspirational leaders, all while gaining world-class experience in one of the most dynamic organizations in the pharmaceutical industry. This is a reality for AbbVie Interns. Cell Line Development Scientists work together to develop lifesaving therapies for patients. The Biologics Drug Substance division is a team of scientists driving scientific excellence and process development through innovative solutions. The team is responsible for all Chemistry, Manufacturing, and Control (CMC) cell line and bioprocess development activities for AbbVie's early-stage products. The BioCMC Developmental Sciences Intern will have the opportunity to learn and work on key aspects of developing fundamental scientific understanding related to AbbVie's projects and processes, including exposure to innovative projects applying advanced gene expression analysis methods to characterize AbbVie's cell lines. A scientifically driven and energetic intern will have the chance to learn from our activities and share his/her expertise in the field of molecular biology, cell biology, and cell culture. Interns will be asked to demonstrate innovation and critical thinking within their project work. Key responsibilities include: Aseptic cell culture DNA/RNA extraction and handling PCR and RT-PCR amplification using droplet digital PCR Collaborate on RNA sequencing ideas and data extrapolation Bioinformatics (surveying databases for information and ideas) Literature Surveys Managing day-to-day lab activities for innovation Qualifications Minimum Qualifications Currently enrolled in university, pursuing a PhD in Cell & Molecular Biology, Biochemistry, or related fields Must be enrolled in university for at least one semester following the internship Aseptic cell culture, molecular biology, and PCR experience Strong theoretical understanding of Gene Expression analysis methods Understanding of primer-probe design and chemistry for PCR amplification Strong verbal and written communication skills Strong problem-solving and time management skills Preferred Qualifications Expected graduation date between December 2026 - June 2027 Exposure to courses of immunology / biochemistry Preferably 2-3 years of lab experience (can include graduate lab experience) Benefits and Amenities Competitive pay Relocation support for eligible students Select wellness benefits and paid holiday / sick time Break rooms stocked with complimentary coffee, tea, beverages, snacks, and cold breakfast items Onsite café and fitness center Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: Benefits and Amenities: Competitive pay Relocation support for eligible students Select wellness benefits and paid holiday / sick time The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://**************/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://**************/join-us/reasonable-accommodations.html
    $38k-44k yearly est. 3h ago

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