Oncology Late-Stage Clinical Scientist (Director, Non MD)
Pfizer 4.5
Pfizer job in South San Francisco, CA
. 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 5 years Clinical Research experience in industry/CRO, OR
* MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR
* BA/BS in a relevant Science discipline and minimum of 10 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 $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.
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 disabilityrecruitment@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 Auto-Apply 29d ago
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Associate Director, Biostatistics
Pfizer 4.5
Pfizer job in South San Francisco, CA
The Associate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role:
* Is an individual contributor role who specializes in creating clinical study designs, performing data analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions.
* Provides statistical input to study designs and can contribute to departmental or cross-functional initiatives to enhance business processes and improve efficiency.
JOB RESPONSIBILITIES
* Serve as a study statistician for assigned clinical studies related to one or more clinical programs.
* Provide statistically sound experimental design and data analysis strategies to meet project objectives with high quality in a timely manner.
* Provide statistical inputs on clinical development plans.
* Contribute to the development of clinical study protocols and author the statistical sections.
* Develop statistical analysis plans and work with programming to create table, listing and figure shells for clinical trials or ad-hoc analyses.
* Develop study randomization specification and verification documents as necessary.
* Perform sample size calculations and assess trial design operating characteristics under various assumptions. Advise the team on the most efficient design to meet study objectives.
* Review CRFs and edit checks and participate in UAT of different systems.
* Review dataset programming specifications, key derived variables, and statistical deliverables.
* Independently derive from source data key efficacy variables and analyses.
* Perform the analyses of clinical trial data, provide statistical interpretation of results, and collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to the clinical study reports, clinical publications, conference posters and presentations.
* Review and contribute to study and project timeline and provide high quality statistical deliverables in a timely manner.
* Provide statistical leadership in clinical study team setting.
* May independently present at department, project team, or Sr. Management meetings.
* May lead inter-department projects involving other contributors.
MINIMUM QUALIFICATIONS
* Demonstrated high aptitude (considered a subject matter expert internally) in key areas of responsibility, which is typically associated with a Ph.D. in Statistics, Biostatistics or a related field with 5+ years of experience, or a master's degree in Statistics, Biostatistics or related field with 7+ years of experience in clinical trials.
High aptitude in:
* FDA/EMA and other regulations
* ICH GCP guidelines
* Drug development process
* CDISC standards and implementation guides
* Statistical methods and applications to clinical trial design and data analysis
* Programming skills in R and/or SAS
* Company SOPs and business practices
* Demonstrated ability to:
* Develop and deliver multi-mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences.
* Manage multiple projects.
* Take on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
* Consistently achieve results, even under tough circumstances.
* Adapt approach and demeanor in real time to match the shifting demands of different situations.
* Build partnerships and work collaboratively with others to meet shared objectives.
* Make sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
* Plan and prioritize work to meet commitments aligned with organizational goals.
PREFERRED QUALIIFICATIONS
* Oncology experience
* Strong statistical research and simulation skills and experience
* 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: Hybrid, must be onsite 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 | (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.
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 disabilityrecruitment@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
$135.1k-225.1k yearly Auto-Apply 14d ago
Finance MBA Leadership Rotational Development Program
PG&E Corporation 4.8
Oakland, CA job
Requisition ID # 168072 Job Category: Accounting / Finance Job Level: Individual Contributor Business Unit: Finance Work Type: Hybrid Finance is a dynamic organization comprised of diverse individuals and teams including Audit and Risk, Controller, Corporate Development and Economic & Project Analytics, Finance and Planning, Investor Relations, and Treasury teams. Together, we are unlocking value for our hometowns, customers, and investors.
Position Summary
PG&E's Finance MBA Rotational Leadership Development Program is a two-year experience designed to develop future finance leaders through hands-on exposure across key departments in a major public utility. Participants complete three 8-month rotations in distinct finance pillars and a strategic group project, gaining broad experience in financial planning, accounting, strategy, risk, audit, and treasury.
Each rotation offers structured, high-impact opportunities to build technical and leadership skills-such as financial modeling, regulatory analysis, process improvement, and executive communication-while contributing to PG&E's operational and strategic goals. Rotational placements vary based on business needs, and participants also engage in professional development and networking activities throughout the program.
PG&E is providing salary information that the company in good faith believes might pay for this position at the time of the job posting. This compensation is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, specific skills, education, licenses or certifications, experience, market value, geographic location, and internal equity.
The salary for this position is $135,000.
Job Responsibilities
MBA responsibilities will vary by rotation and business needs, with assignments tailored to organizational priorities and individual experience. Flexibility, initiative, and alignment with PG&E's values and virtues are essential for a successful and impactful experience.
Sample responsibilities may include:
* Financial Planning & Analysis: Lead budgeting, forecasting, and performance reviews to support strategic decision-making.
* Accounting & Regulatory Support: Assist with financial reporting, tax filings, and regulatory compliance activities.
* Treasury & Capital Strategy: Support financing transactions, liquidity planning, and capital structure analysis.
* Risk & Controls: Evaluate financial and operational risks, contribute to SOX compliance, and recommend control improvements.
* Strategic Projects: Build models, automate processes, and drive initiatives in areas like decarbonization and enterprise planning.
* Leadership & Collaboration: Present insights to senior leaders, foster cross-functional partnerships, and contribute to PG&E's strategic goals.
This development program is 24 months with three 8-month rotations. Before completing the program, rotational candidates will be required to formally apply for a full-time position within PG&E. Each MBA regular status role and responsibility will depend on experience, interests, and performance during the program, and company needs.
Qualifications
Minimum:
* Qualified candidates will graduate with a Masters in Business Administration from May 2025 - June 2026
* Job-related experience, 3 years
Desired:
Professional Experience:
* Proven experience in leadership roles and internships at well-known companies.
* Demonstrated expertise in strategic planning, business development, project management, and quantitative analysis.
Skills and Certifications:
* Proficiency in common business software and analytical tools.
* Relevant professional certifications are a plus.
* Strong soft skills including public speaking, research, customer service, and the ability to work in cross-functional teams.
Industry-Specific Knowledge:
* Specialization in areas such as clean energy, utilities, regulated industry, and financial auditing.
* Experience with renewable energy projects, market analysis, and development initiatives.
Process improvement:
* Solid track record of driving process improvement initiatives
PG&E is unable to provide VISA sponsorship to students on an F-1, J-1 or other student visa for this position.
$135k yearly 35d ago
ExploR&D Clinical Program Lead
Eli Lilly and Company 4.6
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 55d ago
Director, Parenteral Sterility Assurance
Eli Lilly and Company 4.6
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 60d+ ago
Operator, Aseptic Filling (Day Shift)
Eli Lilly and Company 4.6
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
* 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 6am to 6pm on a 2-2-3 schedule
* 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.
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 60d+ ago
Electric Standards and Strategy Engineer
PG&E Corporation 4.8
Oakland, CA job
Requisition ID # 169641 Job Category: Engineering / Science Job Level: Individual Contributor Business Unit: Electric Engineering Work Type: Hybrid The hardworking coworkers of Electric Engineering ensure all manners of electric engineering-including electric standards and process safety, electric design engineering, instrumentation testing and controls, undergrounding, electric regulatory compliance and electric investment planning-are in place to safely enable a strategic and stable workplan for our Electric Operations partners. Our organization is accountable for program planning, financial budgeting, and project execution and delivery of all electric engineering projects. Electric Engineering is comprised of approximately 2,000 coworkers.
Position Summary
This position is represented by the Engineers and Scientists of California (ESC) subject to collective bargaining.
This journey level engineer job requires mastery of an Associate Engineer skills and duties. This position is responsible for providing strategy, engineering, operations, maintenance, and other technical implementation support for the distribution line SCADA/Automation systems. The responsibility of this position increases with experience and demonstrated ability.
This position is hybrid, working from your remote office and your assigned work location based on business need. The assigned work location will be within the PG&E Service Territory.
PG&E is providing the salary range that the company in good faith believes it might pay for this position at the time of the job posting. This compensation range is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, specific skills, education, licenses or certifications, experience, market value, geographic location, collective bargaining agreements, and internal equity.
The annual salary range is:
CA Minimum, $115,128
CA Maximum, $175,080
Job Responsibilities
Is able to perform the job duties of the Associate Level engineer. As Assigned, additional job duties include, for transmission equipment:
* Conduct engineering analyses, studies and review project scope for standards compliance.
* Develop and implement PG&E's electric transmission asset strategy
* Interprets and applies applicable codes and regulations.
* Perform, document and publish equipment ratings
* Assist other engineers, team members, and supervisor by developing, compiling, and providing technical data
* Update and manage databases as required
* Prepare or support incident investigations, equipment failure analyses and reliability studies.
* Comply with FERC, CPUC, CAISO and other regulations and requirements
* Communicate with regulators, customers and other external stakeholders to advance PG&E's objectives.
Qualifications
Minimum:
* BS Degree in Electrical Engineering from an accredited curriculum in the US or the equivalent from outside the US
* 3 years of cumulative experience in electrical engineering, planning and/or operations.
Desired:
* Current and active California PE license
* Able to apply basic power engineering principles and theory.
* Assess and recommend solutions for routine projects
* Familiarity with electric distribution systems
* Experience or comfort with tools such as Tableau, Excel, PowerPoint, ET-GIS
* Background in six sigma process
* Work easily with data to find trends
* Knowledge of reliability metrics such as SAIDI and SAIFI
$115.1k-175.1k yearly 11d ago
Operator, Formulation (Day Shift)
Eli Lilly and Company 4.6
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.
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 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 Lead 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. The Expert and Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff. This position will require travel (2-4 week trips and/or 3-9 month short term assignments) domestically with the opportunity for travel internationally to collaborate, train with, and learn from sites who currently produce our medicines.
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. Senior and Lead Operators will coordinate 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.
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.
Education, Experience, and Skills
* 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
* Must Pass a "fitness for duty" physical exam
* In operation, must have the ability to work 6am to 6pm on a 2-2-3 schedule
* 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.
* 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:
* (Senior and Lead roles) 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 - $38.08
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 35d ago
Oncology Late
Pfizer 4.5
Pfizer job in South San Francisco, CA
. 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 5 years Clinical Research experience in industry/CRO, **OR**
+ MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO **OR**
+ BA/BS in a relevant Science discipline and minimum of 10 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 $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.
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 disabilityrecruitment@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
$82k-104k yearly est. 40d ago
Major Projects Post Award Contract Administrator, Principal
PG&E Corporation 4.8
Oakland, CA job
Requisition ID # 167198 Job Category: Legal Job Level: Manager/Principal Business Unit: Engineering, Planning & Strategy Work Type: Hybrid The Procurement organization is the functional lead for the procurement of materials and services at Pacific Gas and Electric Company. The department collaborates with internal clients and suppliers managing more than $12 billion of annual company spend to develop mutually beneficial total value solutions for goods and services. The department provides the following services to internal clients: procurement of goods and services, strategic sourcing and cost savings, category management, supplier relationship management, execution and outreach, compliance management, ongoing procurement field support and management of the source to pay cycle.
Position Summary
The Major Projects Post Awards Contract Administrator, Principal will be a part of the first dedicated procurement function for capital projects. This role is responsible for ensuring effective contract execution, compliance, and performance management across PG&E's large-scale capital projects. This role serves as the primary liaison between internal stakeholders, suppliers, and project teams to drive timely delivery, control costs, mitigate risk, and maintain contractual integrity.
This position is hybrid, working from your remote office and Oakland based on business needs.
PG&E is providing the salary range that can reasonably be expected for this position at the time of the job posting. This salary range is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, internal equity, specific skills, education, licenses or certifications, experience, market value, and geographic location. The decision will be made on a case-by-case basis related to these factors. This job is also eligible to participate in PG&E's discretionary incentive compensation programs.
Pay Range display:
Bay Area - $132,000 - $226,000
Reporting Relationship
The Major Projects Post Award Contract Administrator, Principal will report to the Senior Manager, Major Projects Procurement
Job Responsibilities
* Manages all post-award activities for multiple major project contracts, including change orders, amendments, renewals, and closeouts
* Monitor supplier performance to ensure compliance with contractual terms, service levels, and safety requirements
* Support creating clear contracts and ensuring thorough documentation, and implementing effective communication and dispute resolution strategies.
* Support developing contract management work process, and enforcing procedures for handling change orders and amendments; ensure all parties agree on adjustments in accordance with contract terms.
* Leads the most complex cross-functional projects and contracts
* Advises senior leadership (internal and external) on contracting strategy and negotiations.
* Negotiates the most complex contract issues independently.
* Leads the effort to identify, analyze, improve existing business processes, or create new ones within the department to meet new goals and objectives.
* Works closely with key stakeholders such as Project Management Director, PMO Director, Engineering Director, and others to ensure alignment.
* Acts as a primary liaison for the contracts team to PG&E's Legal Department.
* Provides active guidance, support, mentorship and training to less experienced contract management staff.
* Develops and delivers contract management training to all stakeholders.
* Collaborates with other PG&E Lines of Business to promote knowledge sharing and use of best practices.
Background Qualifications
Minimum
* Bachelor's (BA/BS) degree or equivalent experience
* Nine (9) years of experience in a similar role executing and managing contracts for major heavy civil, pipeline, or industrial construction projects
Desired
* Master's degree in Construction Management or related discipline
* Experience in developing and managing complex contracting strategies EPC/CMAR/PDB/DB/GMP.
* Certification such as one of the following or related:
* Project Management Professional (PMP)
* Program Management Professional (PgMP)
* Certified Cost Engineer (CCE) certificate
* Lean six sigma certification, green or black belt
* Experience in major construction project controls, cost estimating, terms and conditions negotiations, and scheduling.
* Experience with quality assurance (QA) and quality control (QC) regarding contract documents.
* Subject matter expertise with composition, management, administration, and negotiation of engineering and construction contracts and change orders
* Ability to apply business knowledge, project management methodologies, and best practices.
* Ability to manage conflict constructively with a win-win resolution in mind.
* Knowledge of budget and resource allocation and formulation of contracts, bids, agreements, and RFPs.
* Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
* Analytical, critical, and technical thinking skills. Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
* Ability to develop reports, models, and simulations.
* Prioritizes workload independently based on department priorities and goals.
* Advanced proficiency with Microsoft Office applications (Word, Excel, PowerPoint, and Outlook) and contract information systems and applications (e.g. SRM, Ariba, SAP, scheduling software).
$51k-77k yearly est. 60d+ ago
Maintenance Technician - Night Shift
Eli Lilly and Company 4.6
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 - $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
$71k-101k yearly est. Auto-Apply 24d ago
Operator, Parenteral Visual Inspection (Days)
Eli Lilly and Company 4.6
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.
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 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 Lead roles) will support start up activities required to bring the Inspection department into service. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Expert and Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff.
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. Senior and Lead Operators will coordinate 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 Objectives / Deliverables
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
* Key liaison between operations and support functions.
Requirements (Education, Experience, Training)
Education, Experience, and Skills
* 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
* Must Pass a "fitness for duty" physical exam
* In operation, must have the ability to work 6am to 6pm on a 2-2-3 schedule
* 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.
* 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:
* (Senior and Lead roles) Leadership and the ability to train / educate team members
* STEM degree or certifications
* 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 - $38.08
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
$31k-35k yearly est. Auto-Apply 6d ago
Manager, Catalyze360 IT Contracts & Business Operations
Eli Lilly and Company 4.6
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.
Organization Overview
Lilly Catalyze360 is a 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 TuneLab-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.
Job Summary
The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well.
Key Responsibilities
Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders
Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives
Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization
Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy
Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance
Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance
Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions
Minimum Requirements
Education: Bachelor's degree from an accredited college or university
Experience: 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry
Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
Additional Skills/Preferences
Experience
Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development
Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations
Experience with Contract Lifecycle Management (CLM) system implementation and optimization
Skills
Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions
Advanced expertise in Intellectual Property frameworks for AI/ML efforts
Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries
Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders
Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members
Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset
Additional Information
Travel up to 10% US as needed for stakeholder engagement and vendor meetings.
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
$69,000 - $165,000
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
$69k-165k yearly Auto-Apply 4d ago
Associate - Quality Assurance - Deviation Mentor
Eli Lilly and Company 4.6
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.
The Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and laboratory investigations. This role oversees the training program related to deviation investigations, participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations. The Deviation Mentor also collaborates in regulatory inspections, site inspection readiness, and issue resolution. In addition, this role will serve as the site steward for One Quality Management System (One QMS) during the project phase.
Key Responsibilities:
Deviation Investigation & Guidance
* Provide expert guidance to lead investigators on deviation investigations, including root cause analysis, quality impact evaluations, and technical writing.
* Assist and advise deviation reviewers and approvers on issue investigation matters.
* Lead complex investigations and act as a technical reviewer for deviations and analytical investigations.
* Lead or participate in deviation review boards, ensuring thorough pre-approval and post-approval reviews.
* Support the development and review of deviation trend reports.
* Design and deliver training programs related to deviations and investigations.
* Develop site-specific deviation and investigation metrics.
One QMS Responsibilities
* Manage the transition of the Quality Management System (QMS) from TrackWise to Veeva for the Concord site.
* Collaborate with the global QMS I3 team to align site deliverables and timelines.
* Present progress reports on QMS I3 implementation to site leadership, including key actions and timelines.
* Act as the Power User and Site Instructor for the QMS I3 Veeva system, covering deviations, change controls, and CAPA.
* Author and review documentation as a Subject Matter Expert for the Concord site's QMS I3 implementation.
Qualifications:
* Bachelor's or Master's degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering).
* 5+ years of experience in pharmaceutical manufacturing operations with preference for parenteral manufacturing
* Strong technical writing, critical thinking, and organizational skills.
* Exceptional communication and interpersonal skills, with a proven ability to provide constructive, actionable feedback to enhance technical document clarity and quality.
* Demonstrated talent for fostering a collaborative environment where open dialogue and positive critique drive continuous improvement in deviation writing practices.
* Good knowledge of cGMP, regulatory standards, and quality system requirements.
Preferred Attributes:
* 7+ years in QA roles within the pharmaceutical or medical device industry.
* Experience with GMP systems, including Deviation Management and Document Control systems.
* Advanced technical proficiency in deviation management, CAPA, change control, and product complaint handling.
* Regulatory inspection experience, including readiness and execution
* Familiarity with TrackWise, Veeva, and parenteral product materials.
* Proven ability to lead global or local project implementations and influence cross-functional teams.
Other Information:
* Occasional off-hours or weekend support for 24/7 manufacturing operations.
* Travel: Up to 10%.
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
$63,000 - $162,800
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-162.8k yearly Auto-Apply 5d ago
Consumer Relations Manager (English & French Proficiency Required)
Procter & Gamble 4.8
San Jose, CA job
Working hours: 8am to 5pm or 7am to 4pm, based on Eastern Standard Time (EST). Candidates are required to work entirely on-site for the first five months. Profile: Consumer Relations Accommodations: P&G is committed to providing accommodations to any applicant with a disability during the recruitment, assessment, and selection process. If you need an accommodation related to your disability in order to participate in the recruitment process, please click here to submit your request. If you require an accommodation for the assessment process: 1) submit your request, 2) do not complete either assessment until you have been contacted for documentation verification.
Join our dynamic team as a Contact Center Manager, where your leadership will enhance consumer experiences and drive operational excellence! In this key role, you will oversee daily operations to ensure exceptional service aligned with our brand needs. Responsibilities include managing staff, monitoring contact volume, and fostering a positive work environment. You'll track performance metrics, analyze data, and implement quality assurance programs to boost consumer satisfaction. Additionally, you will oversee scheduling, training development, and advisor performance assessments while managing the budget. Your focus on continuous process improvement will support effective service delivery, with preparation of performance reports for senior management and collaboration with other departments.
Job Qualifications
Must-Have:
* 3+ years of relevant experience in similar positions.
* Advanced proficiency in English (spoken and written) is required.
* Advanced proficiency in French (spoken and written) is required.
Nice-to-Have Skills:
* Proficient in selecting and utilizing digital tools effectively to achieve goals.
* Demonstrated ability to enhance operational performance through user experience, knowledge management, KPIs, data analytics, and vendor management.
* Experienced in continuous improvement methodologies, collaborating with various business units such as accounts payable and master data management.
* Skilled in developing strategies and content that enhance consumer interactions, creating engaging experiences that address inquiries and influence purchasing decisions.
* Strong ability to build relationships with internal teams and external partners to deliver exceptional consumer experiences and leverage insights from research.
* Ensure consumer handling processes meet quality and regulatory standards, protecting both consumers and the brand while maintaining performance metrics.
* Proficient in employing research methodologies to identify consumer problems and design experiments that inform decision-making.
* Understanding of how to develop and enhance brand equity through strategic choices that resonate with consumers and define brand identity.
Important Notes for Candidates:
* Please complete the online assessments within the next 24 hours after your application for the position.
* Please note that the communication process for this job posting may take longer than usual, as it is connected to multiple positions.
* Before submitting your application, we strongly encourage you to review the following material: Hiring Process and Assessment Information. Familiarizing yourself with this content will help you be better prepared for the online assessments and enhance your chances of success.
What We Offer:
* Responsibilities from Day 1, allowing you to take ownership of your projects
* Continuous mentorship from passionate colleagues and formal training opportunities
* A dynamic and supportive work environment that promotes agility and work/life balance
* Flexibility in arranging your work schedule based on personal needs
* A competitive salary and benefits package
About Us:
P&G serves consumers worldwide with a strong portfolio of trusted brands, including Always, Ariel, Crest, Gillette, Pampers, and Tide. Our community operates in approximately 70 countries. For more information about us and our brands, please visit ***********
We are an equal-opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, or disability status. We ensure reasonable accommodations for individuals with disabilities during the application or interview process. Please contact us to request accommodations.
Stay connected with us on social media! Follow us for the latest updates, exclusive content, and more:
LinkedIn ****************************************************
Facebook P&G Careers | Santa Ana | Facebook
Instagram @pgcareerscr
Job Schedule
Full time
Job Number
R000139830
Job Segmentation
Experienced Professionals
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 60d+ ago
Engineering Technician - Day Shift
Eli Lilly and Company 4.6
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.
Engineering Technician - Day Shift
Organization Overview
At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global leader in healthcare, committed to discovering life-changing medicines, advancing disease management, and supporting our communities through philanthropy and volunteerism. We put people first and strive to make a meaningful impact every day.
Position Summary
The Engineering Technician at our Concord, NC facility plays a key role in supporting Parenteral Operations, our customer, by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This position requires hands-on engineering maintenance expertise to assist with equipment setup, operational support, troubleshooting, repairs, and ongoing maintenance.
The ideal candidate will demonstrate a strong understanding of customer needs, collaborate effectively with internal teams, and provide responsive, courteous support. Success in this role requires technical proficiency, problem-solving skills, and a commitment to delivering excellent customer service in a dynamic manufacturing environment.
Key Responsibilities
* Promote a safety-first, quality-always culture in all tasks and interactions
* Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
* Perform condition monitoring, troubleshooting, and provide operational support
* Diagnose and repair precision filling equipment with strong mechanical aptitude
* Collaborate with engineering and production teams to resolve equipment issues promptly
* Assist with equipment setup and changeovers to support production needs
* Adhere to all GMP and quality standards
* Must have the ability to quickly and accurately diagnose the root cause of a problem and properly implement corrective actions to minimize downtime
* Accurately document maintenance activities and corrective actions
* Support cross-functional tasks and assist outside primary responsibilities as needed
* Work independently and manage priorities under pressure
Basic Requirements
* High school diploma or GED
* Minimum of 5 years' experience in production maintenance
Preferred Qualifications
* Strong mechanical aptitude and hands-on technical skills
* Proficient with basic hand tools
* Detail-oriented with a commitment to quality and precision
* Familiarity with safety protocols and proper PPE usage
* Physically able to stand for extended periods
* Effective team player with strong interpersonal skills
* Associate's degree or technical certification in a related field is a plus
* Knowledge of FDA and GMP regulations
* Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
* Ability to quickly learn and apply new procedures
* Experience working in a classified manufacturing environment
* Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
* Strong verbal and written communication skills
* Customer-oriented mindset with a proactive approach
* Analytical thinker with strong problem-solving abilities
Additional Information
* Flexibility to work overtime or adjust schedule based on production demands
* Following a Monday-Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-day shift schedule
* Willing and able to respond to off-hour emergencies as needed
* Open to travel for training and professional development opportunities
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
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 60d+ ago
Global Development Product Lead
Pfizer 4.5
Pfizer job in South San Francisco, CA
This is a senior role within the Pfizer Oncology Late Stage Development organization, combining both product strategy and development responsibilities for a product within a Disease Area. This role is responsible for leading the Global Product Team (GPT) for the product, as well as the clinical development plan and global development team (GDT) for the product. The position will report to the Disease Area Head (DAH).
What You Will Achieve
In this role, you will:
* Leads the GPT and GDT for a specific asset/product
* GDPL may delegate leadership of GDT as appropriate
* Accountable for the clinical development of the product/indication
* Responsible for overseeing the creation and execution of the clinical development plan from the GDT
* Accountable for the creation of an integrated product strategy and delivery through milestones and decision points by leveraging cross functional teams, with the goal of leading to approvals and maximizing product value
* Regular updating and communication with Disease Area Head on key program metrics, milestones, and risks
* Accountable for working with the GPTs to deliver the R&D budget, at or below target, and managing opportunities for savings or re-distributions of funding across programs
* Partner with Oncology Commercial, BD & Commercial Development to valuate US/ex-US opportunities for investment and building Oncology leadership under the direction of the Disease Area Head
* Integrates regulatory and statistical input into clinical trial design
* Drives and implements short- and long-term project vision and strategy, while ensuring alignment across global functions in regards to strategy and direction. Communicate clear strategy to program team and functions and ensures that is reflected in the operation
* Accountable with regulatory for health authority interactions
* Drives talent acquisition among team members and within their sub-teams, including active selection and de-selection and performance management in conjunction with line managers of the core membership of the program team
* Accountable with safety for clinical evaluations and safety decisions
* Primary governance interface for OLT/OSGT
* Accountable with clinical pharmacology, for optimal dose and schedule selection
* Accountable for external input from advisory boards and steering committees into clinical trial design
* Communicates with leadership and governance committees to address program needs, issues, resources, and recommendations. Ensures that presentations and other product communications are clear and effective. Support development of internal and external presentations.
* Drives team objective setting, prioritization and ensure adherence to Disease Area and overarching Oncology plan and strategy
* Drives risk management, issue identification and resolution and contingency planning
* Create a positive team environment that instills trust, encourages challenging assumptions, and ensures clear transparent communications to align around the overall goal/vision for the product
Here Is What You Need (Minimum Requirements)
* MD with minimum of 10 years of relevant experience in the pharmaceutical, academic, and/or medical research environments
* Demonstrated experience working on early and late-stage product development programs including regulatory filings (BLA/NDA, sBLAs/sNDAs), and product launches/life cycle management is strongly preferred
* Proven ability to lead and influence data-driven strategy planning and implementation
* A proactive and strategic thinker, with strong decision-making skills
* Experience working with corporate partners and alliance management
* Proven ability to function effectively across a matrix organization with multiple stakeholders and constituents, with the ability and strength to focus a team to work towards its goals
* Strong leadership and communication skills (including presentation skills) with success in influencing all levels cross-functionally
* Excellent business acumen with demonstrated ability to align teams to corporate strategy to achieve business and project objectives
* Strong staff management and mentoring experience and skills
* Highly collaborative with outstanding relationship building skills
* Experience in Oncology is required
The annual base salary for this position ranges from $295,900.00 to $478,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% 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.
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 disabilityrecruitment@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
$122k-166k yearly est. Auto-Apply 11d ago
Scientist - TS/MS Parenteral
Eli Lilly and Company 4.6
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 Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual
inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring
metrics/methods to ensure a state of capability and control, harmonization of control strategies across process
teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position
that develops and implements a technical agenda and is responsible for providing technical leadership for the
Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in
upstream and external to site activities related to parenteral manufacturing.
Key Objectives/Deliverables:
* Support the assigned Process Team (formulation, filling, or VI) as TSMS representative. • (Associate/Senior) Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
* Represent Concord TSMS team for internal and external communications on a regular basis
* Lead risk management activities as it pertains to product/process
* Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
* Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
* Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
* Identify opportunities and lead technical projects to improve process control and/or productivity
* Serve as interface with upstream suppliers and parenteral product networks
* Drive stability strategy for Concord products
* Provide Audit support as needed
* Identify opportunities and participate in projects to improve process control and/or productivity
Basic Qualifications:
* Bachelor's degree or higher an engineering, packaging science, or related field
Additional Skills/Preferences:
* Pharmaceutical and/or medical device manufacturing experience
* Root Cause Investigation Experience
* Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
* Demonstrated successful leadership of cross-functional teams
* Strong interpersonal and teamwork skills
* Strong self-management and organizational skills
Additional Information:
* Role is Monday through Friday. 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.
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