How you’ll make an impact:

We seek an experienced QC supervisor to manage our growing commercial-level in-house GMP testing groups to support in-process, release and stability for multiple stages of our gene therapy and immune oncology products. This includes data review/release and trending of our analytical test methods and GMP operational support systems ensuring a compliant Quality Control lab.

About the team:

You will interface with multiple Quality Control functions in support of method qualification, transfer and validation activities. In addition will collaborate with Quality Assurance, IT, Manufacturing, Facilities, and other cross-functional teams as required. A strong cGMP, operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. You will also be collaborating internally and externally leading various projects with a team focused on testing of analytical, cell-based, and immunological-based test methods

How you’ll spend your time:

• Review and evaluate raw data at a peer/manager designee review level of all analytical methods (bioassay, flow cytometry, qPCR, and ELISA), as well as sample authorization
• Author, review, and/or approve SOPs/policies and technical reports.
• Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure
• Review, and/or approve quality documents including equipment validation
• Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
• Review and approve phase-appropriate test method validation protocols as needed
• Lead/Participate in providing the necessary information for regulatory filings and inspections
• Lead and support CAPA/Continuous Improvement Initiatives
• Act as manager designee for quality document review and approval

Who you are and what you’ve accomplished:

• May manage 4 direct reports
• BS with 5 years or MS with 3 years in a biotechnology discipline
• 7 years of experience in a cGMP/GxP environment is preferred
• Hands on experience in mammalian cell culture maintenance, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
• Demonstrate a strong initiative and scientific leadership
• Direct experience in authoring and review/approval of SOPs
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
• A passion for addressing the critical unmet medical needs of patients
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
• Willingness to embrace and demonstrate the principles of the 2Seventybio culture