Sr. Associate/Manager - Quality Control
Eli Lilly and Company
4 hours ago
On-site
Boston, MA
Operations
Responsibilities:
- Perform routine potency testing for release and stability of drug substance and drug product using potency software and Veeva LIMS
- Review and approve cGMP analytical data from test methods including mRNA expression, potency, and NGS
- Produce analytical master and working cell banks; support routine testing/qualifications with continuous cell culture
- Participate in method transfers and qualifications (protocol and report authoring)
- Qualify controls, reference standards, and cell banks
- Trend QC assay reagent performance, controls, and system suitability criteria
- Troubleshoot methods and implement improvements through change control
- Author and revise QC SOPs and test methods
- Manage projects for tech transfer, qualification, and documentation
- Support OOS/OOT, investigations, deviations, change controls, and CAPAs for the QC laboratory
- Maintain laboratory equipment and perform routine cleaning
- Engage in laboratory audits
- Receive samples/materials, apply internal labels, and maintain adequate supplies for testing
- Oversee lab-related projects and present risk management/timelines in internal meetings
- Collaborate with Analytical Development and QA for technical method transfer, qualification strategies, and maintenance of reference standards/critical reagents
- Follow safety guidelines, cGMPs, and applicable regulatory requirements
Qualifications (Basic Requirements):
- Bachelor’s degree in chemistry, analytical chemistry, biochemistry, molecular biology, or related area
- 3+ years in the pharmaceutical/biopharmaceutical industry
- Authorized to work in the United States full-time; visa sponsorship not provided
Skills/Preferences (Additional Skills/Preferences):
- Prior gene therapy product testing experience
- 5+ years demonstrated quality experience in a GMP environment
- Experience with GxP document review and data integrity/ALCOA+ principles; working knowledge of applicable FDA CFR
- Experience with cell culture, NGS, aseptic technique, and statistical data software
- Knowledge of cGMP, ICH, FDA, MHRA, JP, and EU regulations
- Experience authoring SOPs/test methods and generating qualification protocols/reports
- Expertise in bioanalytical (cell-based/in-vitro activity assays), physicochemical (HPLC, LC-MS, capillary gel electrophoresis, DSC), and molecular biology (RT-qPCR, NGS, Sanger sequencing)
- Strong written/verbal communication; cross-functional collaboration; problem-solving (e.g., investigations)
- Proficiency in Word, Excel, and electronic quality systems
Additional Information:
- Onsite, in-lab role; requires 4 days in the Boston office
- Location: 201 Brookline Avenue, Boston, MA 02215
Benefits (as stated):
- Eligibility for a company bonus (depending on company/individual performance)
- Comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits (e.g., employee assistance program, fitness benefits)
Application instructions (as stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Perform routine potency testing for release and stability of drug substance and drug product using potency software and Veeva LIMS
- Review and approve cGMP analytical data from test methods including mRNA expression, potency, and NGS
- Produce analytical master and working cell banks; support routine testing/qualifications with continuous cell culture
- Participate in method transfers and qualifications (protocol and report authoring)
- Qualify controls, reference standards, and cell banks
- Trend QC assay reagent performance, controls, and system suitability criteria
- Troubleshoot methods and implement improvements through change control
- Author and revise QC SOPs and test methods
- Manage projects for tech transfer, qualification, and documentation
- Support OOS/OOT, investigations, deviations, change controls, and CAPAs for the QC laboratory
- Maintain laboratory equipment and perform routine cleaning
- Engage in laboratory audits
- Receive samples/materials, apply internal labels, and maintain adequate supplies for testing
- Oversee lab-related projects and present risk management/timelines in internal meetings
- Collaborate with Analytical Development and QA for technical method transfer, qualification strategies, and maintenance of reference standards/critical reagents
- Follow safety guidelines, cGMPs, and applicable regulatory requirements
Qualifications (Basic Requirements):
- Bachelor’s degree in chemistry, analytical chemistry, biochemistry, molecular biology, or related area
- 3+ years in the pharmaceutical/biopharmaceutical industry
- Authorized to work in the United States full-time; visa sponsorship not provided
Skills/Preferences (Additional Skills/Preferences):
- Prior gene therapy product testing experience
- 5+ years demonstrated quality experience in a GMP environment
- Experience with GxP document review and data integrity/ALCOA+ principles; working knowledge of applicable FDA CFR
- Experience with cell culture, NGS, aseptic technique, and statistical data software
- Knowledge of cGMP, ICH, FDA, MHRA, JP, and EU regulations
- Experience authoring SOPs/test methods and generating qualification protocols/reports
- Expertise in bioanalytical (cell-based/in-vitro activity assays), physicochemical (HPLC, LC-MS, capillary gel electrophoresis, DSC), and molecular biology (RT-qPCR, NGS, Sanger sequencing)
- Strong written/verbal communication; cross-functional collaboration; problem-solving (e.g., investigations)
- Proficiency in Word, Excel, and electronic quality systems
Additional Information:
- Onsite, in-lab role; requires 4 days in the Boston office
- Location: 201 Brookline Avenue, Boston, MA 02215
Benefits (as stated):
- Eligibility for a company bonus (depending on company/individual performance)
- Comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits (e.g., employee assistance program, fitness benefits)
Application instructions (as stated):
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation