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Pfizer jobs in Sanford, NC - 98 jobs

  • Manager, Quality Assurance (Quality Risk management)

    Pfizer 4.5company rating

    Pfizer job in Sanford, NC

    Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the site Quality Risk management Lead at Sanford, you will drive compliance and performance excellence. The role will provide oversight of the application of the Quality Risk management program, technical expertise as well as drive compliance initiatives, support inspection readiness and continuous improvement projects. This position will work closely with other site operating units as well as site leadership and the above site QRM team. What You Will Achieve In this role, you will: Leads the integration of Quality Risk Management (QRM) principles and practices into the Quality System, Develops QRM Plan for site Ensures all aspects of the Quality Risk Management lifecycle and program are in place and properly functioning Manages the deployment of site risk facilitators and QRM training Participates in PCT meetings within network Supports risk management during audits/inspections Reports site QRM metrics Ensures deployment of Risk Register and QRM Maturity Assessment Provide technical inputs to evaluate QRM activities and accountable to provide leadership to drive issues to timely resolution. Lead successful and timely execution of quality and compliance improvement initiatives. Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness. Here Is What You Need (Minimum Requirements) Applicant must have a Bachelor's degree with at least 4 years of experience OR Master's degree with more than 2 years of experience, OR a PhD with 0 years of experience OR an Associate's degree with 8 years of experience OR High School Diploma (or Equivalent) and 10 years of relevant experience. Experience in Quality Risk Management Previous experience with leading projects is required. The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. Bonus Points If You Have (Preferred Requirements) Experience interfacing with regulators/inspectors Ability to communicate effectively across diverse functional groups and layers of management. Strong Technical writing skills Able to collaborate and partner cross-functionally In depth knowledge and understanding of GMP regulations and Quality System requirements Other job details Last day to apply: January 20th, 2026 Work Location Assignment: On Premise The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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. Quality Assurance and Control
    $96.3k-160.5k yearly Auto-Apply 14d ago
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  • Bioprocess Technician IV - Day shift 6 am - 6 pm, Vaccines

    Pfizer 4.5company rating

    Pfizer job in Sanford, NC

    Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve In this role, you will: Executes manufacturing operations on the production floor for Downstream/Purification with varying levels of automation. Follow SOPs and batch records for unit operations Supports operation of manufacturing equipment and issue resolution associated with process equipment commissioning, qualification and validation. Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor. Drives for Right first time and continuous improvement execution, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time. Supports audits and observation improvements. Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations. Responsible for remaining current on assigned training. Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas. Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk. Ensures work requests are generated when issues arise with facility / manufacturing equipment. Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS. Ensure and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner. Here Is What You Need (Minimum Requirements) High School Diploma or GED and 4+ years of experience, particularly in a pharmaceutical or other cGMP (Current Good Manufacturing Practices) environment or Associate plus 2 years of work experience or Bachelors plus 0 years of work experience preferred Effective verbal and written communication Proficiency in operating and troubleshooting production equipment Strong understanding of cGMP and safety regulations Ability to maintain accurate documentation and records Experience in a clean room environment Competence in using automated and enterprise systems Effective cross-functional communication skills Bonus Points If You Have (Preferred Requirements) Experience in a pharmaceutical manufacturing environment Knowledge of process improvement methodologies Ability to train and mentor less-experienced colleagues Ability to work independently and as part of a team Attention to detail and commitment to quality Adaptability and flexibility in a dynamic work environment Physical / Mental requirements Requires the moving of heavy equipment and the ability to lift ~40 pounds. Moderate repetitive standing, sitting, bending, and ladder climbing on a daily basis. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals. The incumbent is required to attain knowledge of the operational equipment. The incumbent will be required to assist in solving problems regarding site assessment, specific units used in Biopharmaceutical manufacturing. The incumbent must be able to follow SOPs, MBRs and be able to use a multitude of enterprise systems including SAP, Delta-V, etc. Non Standard work schedule, travel or environment requirements Supports a 24/7 facility. 2-2-3 schedule. Day shift 6am-6pm. Other job details Last day to apply: December 24th, 2025 Work Location Assignment: On Premise The salary for this position ranges from $25.88 to $43.14 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 applies only to the United States - North Carolina - Sanford location. 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. Manufacturing
    $25.9-43.1 hourly Auto-Apply 40d ago
  • Manufacturing Supervisor (Floating)

    Pfizer 4.5company rating

    Pfizer job in Sanford, NC

    Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve In this role, you will: Oversee the production of drug substances or active biological ingredients (ABI), ensuring targets are met and processes remain consistent. Manage quality, compliance, and customer service, including staffing and employee counseling. Ensure team performance is accurate, timely, efficient, and compliant with corporate policies, SOPs, GMPs, and other regulations. Optimize resources to maximize production while maintaining quality and safety standards. Lead and coach production work teams, manage technical resources, and solve complex problems within your expertise. Establish operational activities supporting mid-term goals, recognize development needs, and create opportunities for colleagues. Coordinate activities for equipment and automation changes, participate in daily manufacturing activities, and ensure a safe work environment while collaborating with functional SMEs and trainers to meet production goals and training needs. Here Is What You Need (Minimum Requirements) High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience Strong people management skills Ability to identify, evaluate, and correct potential hazards in the workplace Experience in pharmaceutical manufacturing or a related field Knowledge of current Good Manufacturing Practices (cGMP) Proficiency in managing quality, compliance, and customer service Strong problem-solving skills and the ability to manage complex projects Bonus Points If You Have (Preferred Requirements) General knowledge of scientific principles Experience with production equipment and related procedures Experience in process improvement and innovation Ability to work collaboratively with cross-functional teams Strong analytical and decision-making skills Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use Other job details Last day to apply: January 21st, 2026 Work Location Assignment: On Premise The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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. Manufacturing
    $80.3k-133.9k yearly Auto-Apply 15d ago
  • Computed Tomography Sales Consultant - Radiology - Charlotte, NC

    Bayer 4.7company rating

    Raleigh, NC job

    **PURPOSE** The Computed Tomography Sales Consultant is responsible for driving revenue growth and market share for Bayer's computed tomography (CT) and cardiovascular (CV) portfolio, including injectors, contrast media, and related software and workflow solutions. They generate demand for the CT / CV portfolio by leveraging territory knowledge, strong customer relationships, and consultative expertise across systems, stakeholders, and contracts. The role involves developing deep relationships with radiology stakeholders, imaging managers, procurement leaders, and IT and biomed teams, while effectively navigating health system decision-making processes and engaging the broader Radiology ecosystem (including suites, OEMs, service hubs, radiologists, and system integrators). The Computed Tomography Sales Consultant sells, coordinates, and promotes products and services, while mentoring internal teams and leading impactful sales and marketing presentations. They ensure customer success by delivering clinical and operational economic value aligned with key customer priorities, coordinating resources across Bayer's cross-functional teams, and embedding the Radiology Customer Engagement Plan (CEP) under the Dynamic Shared Ownership (DSO) model. The span of coverage will be Southern North Carolina, covering Charlotte and Willmington; South Carolina, covering Greenville, Columbia, and Charleston, and Northeast Georgia, covering Augusta, Savannah and Athens. The candidate must live within the territory. **KEY TASKS AND RESPONSIBILITIES** + Achieve sales and revenue targets for the CT portfolio within assigned accounts and territory; + Build strong relationships with radiology leaders, CT technologists, procurement, and Value Analysis Committees to expand Bayer's CT presence to promote Bayer Radiology products/services/solutions to exceed sales goals; + Identify key decision-makers and navigate complex buying processes across systems and accounts to build Bayer sphere of influence within the account; + Develop and execute a territory business plan that identifies key accounts, stakeholders, and growth opportunities by establishing clear goals and resource allocation (coverage, sampling, grants, education); + Partner and proactively communicate with account managers (National Account Managers (NAMs), Strategic Account Managers (SAMs) and Account Managers (AMs), working accountably to their delivery on activities) and cross-functional colleagues (Service, Clinical, Medical) to integrate CT solutions into strategic accounts; + Generate quotes and support the proposal process in alignment with SAMs/AMs to ensure consistency and compliance; + Collaborate with CT and MR roles in shared accounts with clear differentiation from MR counterparts, as the CTSC is expected to bring an engineering/technical orientation distinct from the molecule/clinical science focus of the MR role; + Proactively communicate insights with SAMs and Ams; + Utilize enterprise value selling (EVS) tools and business insights to support customer needs and drive value; + Ensure strong customer relationship management (CRM) discipline by maintaining accurate pipeline data, documenting key stakeholders, logging activities, and leveraging sales reports to inform territory strategy; + Act as a proactive business partner to Customer Squad team, sharing insights on customer trends internally and contribute toward strategic account plans; + Provide complete reports on sales, market activity, and technical inquiries to leadership; + Deliver value-focused, insight-driven presentations tailored to CT workflow and outcomes based on deep technical and clinical understanding of CT workflows across the suite; + Monitor market trends, competitor activities, and customer needs, communicating insights to leadership; + Leverage data and reporting to make strategic decisions/accountability and consistency in capturing and managing product pipeline; + Ensure seamless sales handoff and connectivity at initial stages to downstream support teams (service, clinical, medical, etc.) to maintain continuity of customer experience; + Ensure compliance with Bayer policies, regulatory requirements, and ethical standards in all engagements; + Manage resources effectively, including expense reporting, protect company assets, and ensure compliance with pharmaceutical regulation. **WHO YOU ARE** Bayer seeks an incumbent who possesses the following: **REQUIRED QUALIFICATIONS** + Committed to advancing the U.S. Radiology landscape through a deep personal passion for improving patient outcomes; + Bachelor's or advanced degree in business, life sciences, engineering, or related discipline; + Demonstrated track record of achieving sales targets in a complex healthcare environment; + Strong knowledge of CT technology, contrast media, clinical applications, competitive landscape, radiology economics, and decision-making dynamics in health systems; + Demonstrated knowledge of radiology business; + Ability to operate effectively in a cross-functional, matrix environment under a Dynamic Shared Ownership (DSO) model; + Excellent verbal and written communication and presentation skills; + Proven ability to manage customer objections, drive group consensus, and anticipate customer needs; + Comfortable with ambiguity; demonstrates critical thinking and adaptability in rapidly changing environments; + Self-starter with strong time management and organizational skills; able to balance independent work with team collaboration; + Strong competency in Customer Focus, Driving for Results, Integrity & Trust, Ethics & Values and Compassion; + Proficiency in CRM tools (e.g., Salesforce) to drive value; + Skilled in customer engagement, contracting, and influencing decision-making units; + Ability to operate effectively in a cross-functional environment under DSO principles; + Ability to qualify opportunities to ensure focus on high-impact accounts and prospects; + Healthcare sales experience focused on radiology, imaging, or related CT modalities. **PREFERRED QUALIFICATIONS** + Knowledge of Bayer's medical device, software, contrast media, and service portfolio; + Healthcare sales experience (minimum 5+ years preferred), (with 3+ year preferred) focused on radiology, imaging, or related CT modalities; + Ability to use company generated AI tools. Employees can expect to be paid a salary between $ 95,680.00 to $ 143,520.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 1-5-26. \#LI-USA \#LI- AMS **YOUR APPLICATION** Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. **Location:** United States : North Carolina : Charlotte || United States : North Carolina : Residence Based || United States : North Carolina : Wilmington || United States : South Carolina : CHARLESTON NORTH || United States : South Carolina : COLUMBIA WEST || United States : South Carolina : Charleston || United States : South Carolina : Columbia || United States : South Carolina : Greenville || United States : South Carolina : Residence Based **Division:** Pharmaceuticals **Reference Code:** 857323 **Contact Us** **Email:** hrop_*************
    $95.7k-143.5k yearly Easy Apply 42d ago
  • Technician - Process Quality Assurance Floor Support (Night Shift)

    Eli Lilly and Company 4.6company rating

    Parkton, NC 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. Eli Lilly RTP is a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to be part of Team Lilly and work with the latest formulation, isolator, and visual inspection technology. The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas. The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance. Job Responsibilities: Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals. Responsible for ensuring training is completed and remains in compliance. Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues. Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel. Advise Operations and support personnel on quality matters, while driving the site Quality culture. Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems. Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance. Performs daily documented Quality Checks. Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory. Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX). Participate in self-led inspections and provide support during internal / external regulatory inspections. Ability to work cross functionally and work collaboratively with all levels of the organization. Basic Requirements: High School Diploma or equivalent 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. Completion of Post Offer Exam or Completion of Work Simulation if applicable. Ability to work overtime, as requested. Additional Preferences: Demonstrated strong oral and written communication and interpersonal skills. Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred. Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems. Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.) Previous work with combination products or devices with experience with US/EU regulations and notified bodies. Previous experience in GMP production environments. Previous facility or area start up experience. Knowledge of Validation / Qualification activities. Demonstrated decision making and problem-solving skills. Strong attention to detail Proven ability to work independently or as part of a team to resolve issues. Additional Information: Night shift: The position will support a 24/7 operation, working a rotating twelve (12) hour day shift schedule. During the onboarding phase, role will work eight (8) hours Monday-Friday day shift, then transition to the rotating twelve (12) hour day shift stated above upon approval from Supervision. Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $18.02 - $38.61 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
    $93k-121k yearly est. Auto-Apply 59d ago
  • Manufacturing Process Engineer (Nights; 12

    Pfizer 4.5company rating

    Pfizer job in Sanford, NC

    **Use Your Power for Purpose** Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. **What You Will Achieve** In this role, you will: + Spends time on the production floor to proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of production + Serve as the areas technical SME and develops expertise in various manufacturing operations and processes including automation controls that operate and monitor the processes. Role will also support batch record and SOP revisions, electronic batch record design and deployment, commitment ownership, project management, and investigations as needed. + Requires general knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area. + Capable of identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges and initiates appropriate corrective and preventative actions. Acts as a departmental liaison with primary support groups such as engineering, technical operations, quality control, quality assurance, development, and utilities. + Primary point of contact for shift technical support and issue resolution + Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc.) + Uses scientific and Operational Excellence tools/techniques to identify areas to optimize yield and/or and improve efficiencies + Reviews and contributes to applicable documentation (i.e. MBRs, SOPs, etc.) + Ensures equipment requirements can meet processing needs + Participates in process operational improvements + Focuses on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics. + Knows the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise, and coach their teams. **Here Is What You Need** **(Minimum Requirements)** + High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience + Strong leadership and teamwork skills. + Ability to work independently and ability to apply problem-solving / troubleshooting skills in a fast-paced environment. + Ability to work collaboratively with cross-functional teams + Relevant pharmaceutical manufacturing experience and knowledge of current Good Manufacturing Practices (cGMP). **Bonus Points If You Have** **(Preferred Requirements)** + Relevant automation, eMBR, and scheduling system experience. + Experience in process improvement and innovation + Strong analytical and decision-making skills + Experience with managing projects. **Physical / Mental requirements** + lifting, sitting, standing, walking, bending, ability to perform mathematical calculations **Non-Standard work schedule, travel or environment requirements** + Schedule: 2-2-3 rotation, Nights (6pm-6am). **Other job details** + Last day to apply: January 21st, 2025 + Work Location Assignment: On Premise The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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. Engineering
    $80.3k-133.9k yearly 14d ago
  • Cardiovascular Health and Science Professional (HSP)

    Pfizer 4.5company rating

    Pfizer job in Raleigh, NC

    **Cardiovascular Health and Science Professional (HSP) - Wilmington, NC** All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues can grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and can impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer has a deep heritage and leadership in cardiovascular disease, and we are committed to providing breakthroughs that change patients' lives. An integral part of Internal Medicine, the Cardiology (CARD) Team's mission is to promote a breakthrough therapy for patients suffering from NVAF or VTE. The CARD Health & Science Professional (HSP) is responsible for increasing territory sales and relationship development with assigned customers and accounts by engaging in product promotion and determining the best strategies to manage their business. A CARD HSP should possess customer, market, and business acumen, analytical skills, and strong product and disease state knowledge; demonstrate ability to drive sales, promotional and strategic business development and management skills, and in-depth customer engagement expertise both in-person and virtually; demonstrate outstanding communication and teamwork skills; be adept in the operation of digital and virtual tools; and be effective at working remotely in collaboration with cross-functional internal teams to address customer needs and compliantly deliver on Pfizer business objectives. **ROLE RESPONSIBILITIES** + Drives sales in assigned territory. + Engages with customers both face to face and virtually. + Develops and implements effective business and territory call plans; effectively identifies and implements live/virtual engagement strategies with customer to maximize overall effectiveness and impact. + Effectively builds rapport and relationships with customers in both live and virtual environments; uses judgment to maintain customer engagement by successfully utilizing existing and ever-changing digital tools effectively for successful customer engagement. + Understands and leverages internal reports and analytics to assist with identifying, developing, and implementing strategic business opportunities. + Compliantly leverages product and disease state knowledge to appropriately educate providers on unbranded and branded product value proposition for relevant patient populations and effectively and strategically utilizes approved clinically oriented disease state information and patient resources, as applicable. + Demonstrates strong teamwork capabilities to collaborate effectively and compliantly across the organization to address customer inquiries and advance Pfizer objectives. + Completes all administrative expectations on time and compliantly. **BASIC QUALIFICATIONS** + Bachelor's Degree. + Minimum 2 years of experience in one or more of the following; OR an associate's degree with 6+ years of experience; OR high school diploma (or equivalent) with 8+ years of **relevant** experience.- Professional Sales or Promotional Activity.- Small Business Owner or other Entrepreneurial experience, Marketing, Customer Service and/or Account Management.- Relevant Healthcare/Scientific roles (e.g., RN, Pharmacist, PT, OT, etc.).- Educator (e.g., Teacher, Principal).- Full Time Military experience. + Must live within 25 miles of the border of the territory. + Valid US driver's license and driving record in compliance with company standards. Any DUI/DWI or other impaired driving citation within the past 7 years will disqualify you from being hired. **PREFERRED QUALIFICATIONS** + 1 year of pharmaceutical, biotech, medical sales and/or medical related marketing. + Strong track record of sales or marketing success, strong territory management skills, outstanding communications skills, as well as demonstrated teamwork, leadership ability and accountability. + Experience with applicable disease states, therapeutic area, and products. + Knowledge of posted territory customers and markets (prescribers/HCPs/institutions/organizations). + Reside within the territory boundaries. **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS** + Ability to travel to all accounts/office locations within territory. + Depending on size of territory and business need, candidates may be required to stay overnight as necessary. **OTHER JOB DETAILS** + Last Date to Apply: January 26, 2026. + Geography includes: Wilmington, New Bern, Jacksonville, and Kinston in North Carolina. + Work Location Assignment: Remote - Field Based. The annual base salary for this position ranges from $85,000 - $186,700. **During initial new hire sales training, you will be classified as a salary non-exempt employee which entitles you to overtime pay. Upon your training certification, you will become an overtime exempt employee.** In addition, this position offers an additional quarterly Sales Incentive bonus. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits| (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. **Sunshine Act** Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. **EEO & Employment Eligibility** Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email 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. Sales
    $27k-38k yearly est. 8d ago
  • Sr. Director - Process Operations Drug Product MSAT

    Eli Lilly and Company 4.6company rating

    Parkton, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 145 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People. Lilly is making medicines at a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. The Technical Services / Manufacturing Science (TS/MS) Director is responsible to provide leadership to the TS/MS function for the Lilly RTP site. This includes implementing and overseeing the control strategy aspects of the parenteral, device assembly, and packaging operations. Additional responsibility includes establishing and implementing the organization's functional agenda in alignment with the business and strategic plan priorities. The TS/MS Director is a member of the RTP Site Lead Team. Key Objectives/Deliverables: Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence. Provide Health, Safety and Environmental (HSE) and Quality leadership for areas of responsibility. Ensure function meets cGMP requirements. This role has direct interaction with Regulatory Agencies during site inspections. Support Site Leadership to build a diverse and capable site organization. Talent management, development, and retention within the RTP organization (and beyond). Provide site functional leadership and develop objectives to deliver Business and Strategic Plan Goals as it relates to safety, quality, and technical effectiveness and efficiency. Oversee the manufacturing of RTP products process control and validation strategy. The scope of the role includes those commercially manufactured and targeted for RTP in the device assembly, packaging, and syringe filling operations. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Lead risk management activities as it pertains to products Support the delivery of equipment and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation. Support and/or lead TSMS technical projects to improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the tech agenda Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability Develop local processes and procedures for the TS/MS function Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps. Ownership of the Site Validation Plan and lead site validation efforts Ownership of the Site Sterility Assurance Plan Drive stability strategy for RTP products Ensure the function is aligned and driven to meet production throughput goals including daily operation, deviation and change management, variability reduction, and equipment/system reliability. Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance. Active leadership in the implementation of Lean principles and the site Value Stream Map Partner with Engineering, Quality and Operations leadership meet deliver operational results. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA). Represent RTP capabilities to an increasing global customer base, other Lilly sites and corporate groups. Continuous improvement champion Minimum Requirements: At least 10 years cGMP parenteral manufacturing experience At least 5 years technical management or leadership experience including leading or working effectively with a cross functional group Excellent interpersonal, written and oral communication skills Strong technical aptitude and ability to train and mentor others Ability to handle multiple competing priorities Additional Preferences: Demonstrated regulatory inspection experience Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment Previous equipment qualification and process validation experience Previous experience with deviation and change management systems Education Requirements: Bachelors Degree in chemistry, engineering, or biology Other Information: The position is for the Lilly Research Triangle Park site. Ability to work 8 hour days - Monday through Friday Ability to work overtime as required Limited travel < 5% Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $239,800 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
    $163.5k-239.8k yearly Auto-Apply 6d ago
  • Senior Medical Science Liaison- Autoantibody Pipeline-South

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison Job Category: Scientific/Technology All Job Posting Locations: Nashville, Tennessee, United States, Raleigh, North Carolina, United States Job Description: Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine. The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values. Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate. The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices. The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination. The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for. The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation. The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%. Responsibilities: Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory. * Responsible for developing and maintaining a field strategic plan. * Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs. * Presents data and information in a manner appropriate to the audience and request. * Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process. * Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people. * Anticipates the responses of various individuals and teams based on their vantage point and perspective. * Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities. * Executes Research Initiatives: * Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication. * Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams. * Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings. * Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen. Consistently demonstrates strong scientific acumen. * Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news. * Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community. * Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners * Sets aside time for self-driven learnings on current scientific landscape. * Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings. * Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings. Continuous support Department Operations and Internal Partners: * Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities) * Maintain focus and composure in uncertain circumstances with minimal direction. * Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development * Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis. * Demonstrate the ability to partner with others to lead or participate in large scale projects. * Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines. Qualifications Required: A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience) Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Ability to travel up to 70 %. Preferred: Launch experience in rare disease is highly preferred. Significant experience giving presentations is highly preferred. Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote Required Skills: Preferred Skills: Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
    $90k-126k yearly est. Auto-Apply 9d ago
  • Sr. Manager - QA Assurance

    Eli Lilly and Company 4.6company rating

    Parkton, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours day-shift (2-2-3) 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 $94,500 - $138,600 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
    $94.5k-138.6k yearly Auto-Apply 17d ago
  • Maintenance Technician II

    Pfizer 4.5company rating

    Pfizer job in Sanford, NC

    Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they require when they need them. By collaborating with our forward-thinking engineering team, you'll contribute to delivering medicines to the world more swiftly by envisioning new possibilities and taking decisive action. ROLE SUMMARY Our technicians at MC&U play vital roles in ensuring timely delivery of medicines to the patients. This role requires a good technical foundation, the ability to handle moderately complex tasks, troubleshooting ability, and adherence to compliance standards. Technicians at this role are responsible for performing operational tasks with moderate autonomy and contributing to process improvements. ROLE RESPONSIBILITIES Execute routine operational tasks following established procedures. Ensure accuracy and compliance with GMP and safety standards. Apply technical knowledge to improve efficiency, throughput, and quality in daily operations. Assist in troubleshooting process issues and escalate complex problems as needed. Manage own workflow and begin prioritizing tasks to meet team deliverables. Collaborate with team members and contribute to team success by sharing acquired knowledge. Maintain accurate documentation of work performed and report deviations promptly. Incorporate new and innovative work processes and ideas into daily tasks when appropriate. Support preventive and corrective maintenance activities and utilize CMMS systems for work order management. BASIC QUALIFICATIONS High School Diploma or equivalent. Good understanding of procedures, techniques, tools, materials, and equipment relevant to technical operations. Ability to follow standard operating procedures for tasks that may vary in complexity and timing. Basic troubleshooting and problem-solving skills in structured environments. Familiarity with compliance standards and safety protocols in GMP settings. Effective communication and teamwork skills. Time management skills and ability to work under moderate supervision. Familiar with Pfizer Enterprise systems. Ex: QTS, EAMS, PDOCs. PREFERRED QUALIFICATIONS 2+ years of maintenance experience in a GMP-regulated pharmaceutical, biotech, or medical device manufacturing environment. Good mechanical skills in maintaining and troubleshooting pharmaceutical manufacturing equipment such as, pumps, heat exchangers, centrifuge, autoclaves, HVAC systems, central utilities systems (York chillers, gas fire boilers, pharma grade air compressor), clean steam generators, and water purification systems (WFI, RO, DI). PHYSICAL/MENTAL REQUIREMENTS Position requirements are typical for a manufacturing plant-based work environment with significant shop floor exposure. Routine lifting, sitting, standing, walking and bending is required. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This role is standard Monday through Friday work shift. Alternative work schedules may be required to support specific project-related activities. On call duties may also be required. Work Location Assignment: On Premise The salary for this position ranges from $25,88 to $43,14 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 applies only to the United States - North Carolina - Sanford location. 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. Engineering
    $25 hourly Auto-Apply 7d ago
  • Lead - Manufacturing Operations Systems

    Eli Lilly and Company 4.6company rating

    Parkton, NC 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 Manufacturing Operations Systems specialist role will report to an Associate Director of Packaging Operations. The Manufacturing Operations Systems specialist will be responsible for owning initiatives and process improvements, acting as a liaison between operations and multiple functional groups to support event management, change controls, etc. The Manufacturing Operations Systems specialist will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations. Key Objectives/Deliverables: Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Packaging areas. Monitor and build a strong safety culture Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations. Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). Identify changes required for MES and ensure they are implemented consistently with operational practices. Work with EWM, IDS and Master Data Team to support launch and ticket builds Lead training and troubleshooting for operations. Work closely with Logistics on the release of orders Understand and influence the manufacturing control strategy for their area. Trained as a Deviation Investigator Development and monitoring of metrics for the area Aid in issue resolution, batch/product approvals, and production schedule execution. Lead specific activities of the process teams. Key Objectives/Deliverables: Requirements (Education, Experience, Training): High School Diploma or equivalent Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals Technical or Science degree preferred Experience with cGMP environment Experience with EWM and SAP environments and transactions Career interests in Operations Leadership Device Assembly or Packaging experience Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA. Excellent interpersonal, written and oral communication skills Other Information: Ability to travel up to 10% Must be flexible to attend meetings or support off-shifts (operations is 24/7) 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 $28.84 - $46.54 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
    $102k-128k yearly est. Auto-Apply 8d ago
  • Technician - Quality Control - Incoming Materials

    Eli Lilly and Company 4.6company rating

    Parkton, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The Incoming Materials Technician performs goods receipt, material sampling, outbound shipping process and incoming inspections including visual inspection and measurements, utilizing SAP and SmartLab systems. Will also be responsible for delivering samples to laboratories and maintaining retention samples. Key Objectives/Deliverables: Practices safety behaviors with proper personal protective equipment (PPE) and lifting techniques. Supports all health, safety and environment (HSE) Corporate and Site Goals. Documenting inspections in accordance with procedures and specifications. Ensuring materials not meeting specifications are quarantined, per local procedures. Communicate with QA Disposition team to ensure materials are released in a timely manner, as to not delay production. Identifies and assists in resolving issues on inbound shipments (i.e. Incorrect quantity or product, contamination, etc.). Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.) Ensures supplier complaints/remarks are initiated for materials not meeting Lilly expectations. May participate in investigations regarding materials or service complaints. Authors/revises SOPs, materials specifications, as needed. Interacts with other quality functions and supports material related Supplier Change Notifications (SCN). Participates in/supports regulatory inspections, as needed. Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands. Excellent interpersonal and networking skills. Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others. Demonstrated understanding of cGMP regulations related to Inspection applications. Strong attention to detail. Proficient in computer system applications. Requirements (Education, Experience, Training): Minimum High School Diploma Preferred attributes but not required: Previous facility or area start up experience. Previous experience in GMP production and warehouse environments. Understanding of statistical tools and analysis. Experience in inventory management systems (EWM, SAP, etc.) Experience with raw material sampling. Experience with measuring printed packaging materials. Experience working in classified spaces. Additional Information: Rotating 12-hour day shift (2-2-3 Schedule) Ability to work on call and/or off shift in support of a 24/7 manufacturing facility. Ability to work overtime 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 $18.02 - $38.61 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
    $51k-65k yearly est. Auto-Apply 9d ago
  • Technician - Material Preparation (Night Shift)

    Eli Lilly and Company 4.6company rating

    Parkton, NC 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: 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 35,000 employees 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 serve an extraordinary purpose. For more than 140+ years, we have worked to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. We explore how next generation therapeutics, new technologies, and data analytics can improve patient health and the healthcare system. Our team shares a real passion for challenging conventional wisdom and creating an environment that embraces creative, break-through concepts. 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). Responsibilities This role will be responsible for execution of daily operational tasks defined by the shift lead/supervisor. Primary area of responsibility will be focusing on material preparation activities to support filling/dispensing/formulation processes. Night shift role from 1800 to 0600 with a 2-2-3 shift rotation. Key Objectives: Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment. Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleanings, etc.). Attain and maintain qualification for the operation of assigned process equipment and duties in the area. Identify opportunities for operational improvements. Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision. Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Must be willing to work 12-hour shifts (2-2-3 schedule). Candidate must be flexible and be willing to perform non-routine work with Safety & Integrity in mind at all times. Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.) Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Basic Requirements: Ability to gown and work in controlled classified areas (Grade C and Grade D). High School Diploma or equivalent. Ability to effectively communicate (written and verbal). Flexibility and problem-solving skills. Basic digital literacy (desktop software/web browser) is required. Training and qualifications are documented on a web based application. Must pass a “fitness for duty” physical exam. Ability to work 12-hour shifts on days (2-2-3 schedule) with additional overtime as the need arises. 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. Ability to wear safety equipment required (safety glasses, safety shoes, protective gloves etc.). Additional Skills or Preferences: Skills/Preferences: Knowledge of current Good Manufacturing Practices (CGMPs). Previous experience working in operations/pharmaceutical industry. Previous experience in a Grade C environment. Knowledge of lean manufacturing principles. BioWork Certification. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $17.30 - $34.38 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $79k-104k yearly est. Auto-Apply 16d ago
  • Director/Senior Director, Global Process Owner - Sterility Assurance QMS

    Eli Lilly and Company 4.6company rating

    Raleigh, NC job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ 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. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong 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, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * 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 Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. 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 $151,500 - $264,000 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
    $151.5k-264k yearly Auto-Apply 60d+ ago
  • Manager, Technical Compliance and Data Integrity Lead

    Novartis 4.9company rating

    Durham, NC job

    The Manager, Technical Compliance, is responsible to support the DI Lead at Gene Therapies North Carolina Site on the Data Integrity Program and support the quality risk management program, including creation, implementation, defining, monitoring and reporting KPIs, creating solutions for KPI improvement and continuous improvement of the program. In addition, the Manager is responsible for the maintenance and monitoring of Quality Engineering and QA IT. The manager will also be responsible for being the Data Integrity Deputy for the GTxNC site. Job Description Location: This position will be located in Durham, NC and will be able to work on Hybrid schedule Key Responsibilities Manages a team that oversees quality engineering and QA IT. Manages the team to ensure on time delivery of compliance activities related to QA IT and Quality Engineering. Manages the staff responsible for the regulatory CMC related launches and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements Supporting the Maintenance and Monitoring of the Quality Risk Management Program Assists the DI Lead with proactively drives establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program. Serves as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools. Identifies and maintains a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.). Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture. Drives continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc. Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties. Facilitates the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.). Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk. Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy. Responsible for supporting QA approval of quality management records for the QA quality systems team. Essential Requirements: BSc in Chemistry, Biology, Pharmacy, business, or related experience. Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred. 10 years' experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries. Experience in advanced therapies (CGT, RLT, etc) is preferred. Experience with of industry Data Integrity related experience. Prior experience with aseptic manufacturing is preferred. Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, preclinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred. Knowledge of applicable cGMP regulations, for example, FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills. Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations. Experience working in a diverse, fast-paced, local and global SME matrix environment, with ability to drive and manage change. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $114,100 and $211,900 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Hybrid EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $114,100.00 - $211,900.00 Skills Desired Agility, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, People Management, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Sop (Standard Operating Procedure) , Technological Expertise
    $114.1k-211.9k yearly Auto-Apply 14d ago
  • Technician - Visual Inspection

    Eli Lilly and Company 4.6company rating

    Parkton, NC 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 designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build the facility of the future from the ground up. Responsibilities: During the project phase, the Visual Inspection Technician will support commissioning/qualification activities required to bring inspection lines, utilizing semi-automated and automated technology, into service as well as supporting site operational readiness activities. This role includes the opportunity to become a subject matter expert for the inspection equipment/process with the potential for development into a Line Lead or other leadership role. This position may require domestic travel based on business need. After project phase completion, this role will be responsible for the safe operation of highly automated equipment used to inspect syringes. The Inspection Technician is expected to model current Good Manufacturing Practices and ensure compliance with all safety standards. They will support the Line Lead in development of operators and identification of opportunities for operational improvement. Key Objectives Provide commissioning, qualification, and operational readiness support during project phase. Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment. Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. Support leadership on the manufacturing floor by ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients. Proactively monitor documentation and product quality; properly documenting all activities and reporting issues to supervision. Key support for leadership during troubleshooting, functions as reliable point of contact for issue escalation on the shop floor Assist Supervisor in the development and training of shift operators. Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Basic Requirements: High School Diploma or equivalent Minimum 1-year relevant experience, (education may be substituted for experience with manager discretion) 2+ years relevant experience in pharmaceutical, or equivalent regulated industry Additional Skills/Preferences: Demonstrated ability to train and coach others Ability to effectively communicate (written and verbal) Flexibility and problem-solving skills Scientific/technical degrees or certifications Knowledge of current Good Manufacturing Practices (CGMPs) Previous experience utilizing semi-automated and automated visual inspection equipment Previous experience with pre-filled syringe (PFS) technology Previous experience with Manufacturing Execution Systems and electronic batch records Knowledge of lean manufacturing principles Additional Information: Ability to conduct and qualify machine operation trainings, including defect detection for syringes. Must be able to stand for several hours and bend as needed for tasks such as equipment cleanings and line clearances. Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.) Ability to work 12-hour shifts on days (2-2-3 schedule) Ability to work overtime as required Ability to travel during Project Phase and < 5% after startup Ability to pass an annual job fitness exam Quick Benefit 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) $3,000 sign-on bonus Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources (Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $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
    $84k-122k yearly est. Auto-Apply 15d ago
  • Institutional Spec Sales Consultant - Raleigh, NC

    Bayer 4.7company rating

    Raleigh, NC job

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Institutional Spec Sales Consultant - Raleigh, NC Institutional Spec Sales Consultant - Raleigh, NC Institutional & Specialty Sales Consultant, Cardiology - Raleigh, NC PURPOSE The Institutional and Specialty Sales (ISS) team is being established to lead and drive launch activities for indications within the CVR portfolio. Responsibilities include driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for top priority Institutions (i.e., Hospitals and Health Systems), Cardiologists and Nephrologists both in the Institutional and Community settings. The ISS reports to the CVR Area General Manager (AGM) and will be an integral part of the Area Customer Squad, collaborating closely with Marketing, Market Access, Patient Services, and other internal partners, as appropriate, to drive the US Pharma outcomes. The span of coverage will be within the (Territory) metropolitan area. Travel up to 50% within the territory. The position is residence based. The candidate must be domiciled within the territory. KEY TASKS AND RESPONSIBILITIES The primary responsibilities of the Institutional & Specialty Sales Consultant are to: Drive clinical demand, education and sales, building deep understanding of disease state, unmet needs and treatment options to effectively educate healthcare professionals and business stakeholders on the unique benefits of assigned products while balancing both efficacy and safety through detailing of approved clinical information for community-based healthcare professionals and health systems; Build institutional advocacy to drive formulary/pathway/protocol adoption of cardiovascular-renal brand(s) to drive appropriate pull-through of approved products; Develop, co-create with external and internal stakeholders and implement strategic business plans for identified top strategic Institutions with an in-depth understanding of local market dynamics that influence product sales; Demonstrate expertise and knowledge of disease state, the marketplace, competitors, industry, and cross-functional activities/plans as well as possess analytical rigor to anticipate and identify business opportunities and challenges; Build key business relationships within prioritized customers in the community and including key stakeholders at the Institutions (i.e., C and D Suite and Head of Pharmacy, Head of Quality), Cardiologists and Nephrologists; Manage the P&T committee processes at the priority Institutions; Collaborate with the cross functional and Area Customer Squads to develop and pull through the strategic partnerships with key customers; Provide support to Area General Managers in strategic projects, as needed; Leverage and embrace emerging technologies to enhance performance, while continuously striving to improve your proficiency; Understand and comply with pharmaceutical industry guidelines and regulations and apply high ethical standard in day-to-day work. WHO YOU ARE Bayer seeks an incumbent who possesses the following: REQUIRED QUALIFICATIONS Bachelor's degree or 10 years of relevant sales experience in competitive landscapes in lieu of a Bachelor's degree; Deep expertise and understanding of the cardiovascular and/or renal therapeutic area(s); Experience launching new products and product indications; Excellent facilitation and verbal/written communication skills; Ability to work under pressure and meet short deadlines; Ability to comply with any customer credentialing and safety requirements (e.g., up-to-date vaccinations, trainings); Valid driver's license and clean driving record required. PREFERRED QUALIFICATIONS Advanced degree (preferably in the Life Sciences, Pharmacy or business-related field;) 5 years of successful pharmaceutical/biotech/medical sales experience in competitive landscapes; Experience selling in Institutions and clinic settings and navigating the P&T committee process; Experience in establishing and pulling-through in-patient to out-patient protocols . Employees can expect to be paid a salary between $120,960 to $181,440.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least 1/23/2026. #LI-US #LI-AMS YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. Location: United States : North Carolina : Raleigh Division: Pharmaceuticals Reference Code: 858993 Contact Us Email: hrop_*************
    $121k-181.4k yearly Easy Apply 8d ago
  • Manufacturing Process Technician - Packaging (Day Shift)

    Eli Lilly and Company 4.6company rating

    Parkton, NC 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 Manufacturing Technician/Operator will work in the RTP Packaging area, where Lilly autoinjector devices are assembled and packaged. Technician/Operator will be responsible for the safe operation of highly automated equipment producing products of the highest quality for Lilly patients. Responsibilities: Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment. Setup and operate highly automated equipment in the Packaging area. Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleaning Logs, etc.). Attain and maintain qualification for the operation of assigned process equipment and duties in the area. Identify opportunities for operational improvements. Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision. Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance. Will 12-hour shift (2-2-3 schedule) Currently in the startup phase of operations. Candidate must be flexible and be willing to perform non-routine work, with Safety & Integrity in mind at all times. Basic Requirements: High School Diploma/GED required. Additional Skills/Preferences: Previous experience working in a GMP environment preferably in the pharmaceutical industry. Strong ability to multitask. Ability to demonstrate attention to detail. Ability to develop independence in performing daily tasks. Collaborative work ethic with a strong bias for action Demonstrated ability to train and coach others. Ability to effectively communicate (written and verbal) Flexibility and problem-solving skills Basic computer skills (desktop software) are required. 3+ years relevant experience in pharmaceutical, or equivalent regulated industry Knowledge of current Good Manufacturing Practices (CGMPs) Previous experience with Manufacturing Execution Systems and electronic batch release. Knowledge of lean manufacturing principles Additional Information: Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.) Ability to work overtime 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 $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
    $63k-82k yearly est. Auto-Apply 8d ago
  • Associate Coordinator Quality Control Mgmt

    Novartis AG 4.9company rating

    Durham, NC job

    The Associate Coordinator, Quality Control Sample, leads sample control support at the assigned site/laboratory. This role is located on-site in Durham, NC. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you. About the Role Key Responsibilities: * Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and collection of data. * Adherence to all GMP requirements, a proficiency in understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations and inspections/audits. * Manage sample tracking and the inventory system to track commercial and development samples. * Generate sample submission forms for various testing facilities and process returned results. * Collect sample forecasts to ensure lead time notice. * Confirm testing was complete when sample invoices arrive. * Follow/track international shipments, and alert logistics group of any customs clearance issues. * Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs. * Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments. * Execute protocols to support network stability, qualified material programs and pipeline product studies. * Create and continuously improve sample management procedures and processes. * Communicate with other departments and sites including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs. * Write and revise documents such as SOPs and technical reports. * May support the Manager for activities related to training of employees, coordination of tasks, compliance with GMP, and identifying and implementing corrective and preventive actions. * Support for third party testing laboratories and manage testing turnaround times for testing metrics. * Support new implementations of LIMs programs including updates and LIMs activities. * Create/maintain change controls to ensure compliance with regulatory requirements and company/polices. * Act as subject matter expert for sample management procedures. * Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality control. * Support Stability sets and pulls including aliquoting and shipping during the study. Requirements: * High School degree with 8 years related experience in a GMP Quality Control Laboratory or Associate's degree with 6 years related experience in a GMP Quality Control Laboratory OR * Preferred, Bachelors' degree plus 4 years related experience in a GMP Quality Control Laboratory. * Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory. * Excellent oral and written communication skills with strong technical writing experience required. * Able to work independently and effectively within the group, within Quality, and across the site. * Ability to work in both paper based and electronic laboratory information management systems. The salary for this position is expected to range between $32.10 and $59.61/hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
    $32.1-59.6 hourly 15d ago

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