The Role:

The Associate Director of Quality Control is responsible for overseeing the QC Cellular Therapy analytical laboratory, testing, and staff at our BaseCamp facility in Waltham. This position will work with Quality management and Analytical Development to implement the laboratory systems and testing strategies for ElevateBio’s cell and gene therapy programs. Additionally, the Associate Director will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.

Here’s What You’ll Do:

• Develop, implement, and maintain laboratory systems in compliance with applicable GMP practices and regulations.
• Draft, review, and approve SOPs, test methods, specifications, and associated protocols and reports.
• Co-Qualify/Validate or Transfer test methods with Analytical Development Tech Transfer team.
• Oversee daily laboratory operations, including equipment maintenance and calibration, routine analytical testing, and results reporting in LIMS.
• Collaborate with other QC functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing/Logistics) to ensure all testing is initiated and completed within established timelines.
• Review and approve analytical testing excursions, including deviations, CAPAs, and OOSs.
• Develop metrics to evaluate and monitor the performance of the QC cellular analytics laboratory.
• Support inspections and facility audits.
• Hire, train, and mentor laboratory staff.

Requirements:

• B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 10 years of experience in GMP QC laboratory setting, preferably in a cell and gene therapy manufacturing environment.
• Significant experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMPs, SOPs, and Quality system processes.
• Excellent organizational skills.
• Experience performing laboratory investigations.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.