Senior Specialist II, Quality Control Validation (Cell and Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite at the manufacturing facility

Salary: $150,000–$200,000 per year

Company

Technology-driven biotechnology company providing integrated technologies, services, and manufacturing expertise for advanced cell and gene therapies.

What you will do

• Define validation strategies, plans, and protocols for quality control methods based on regulatory, industry, and client requirements.
• Coordinate validation activities with Analytical Development, QC testing, QC management, QA, and customers.
• Analyze validation data and report results.
• Assess test methods, equipment, software, and SOPs for commercial manufacturing readiness.
• Oversee change controls and support inspections and facility audits.
• Hire, train, and mentor supporting staff as needed.

Requirements

• Bachelor’s degree in Biology, Molecular Biology, Chemistry, or a related technical discipline with at least 8 years of experience in a GMP QC laboratory, or a master’s degree with at least 6 years of experience.
• Expertise in cell and gene therapy testing methods, including qPCR, ddPCR, flow cytometry, ELISA, and cell-based assays.
• Experience with method validation for commercial products.
• Strong knowledge of GMPs, SOPs, quality system processes, data analysis, and organization.
• Ability to work independently and communicate with scientific and technical personnel.
• Ability to stand, walk, bend, stretch, and perform repetitive arm, wrist, and hand movements for extended periods.

Nice to have

• Experience in a cell and gene therapy manufacturing environment.
• Experience with electronic systems such as LIMS, CMMS, QMS, or ERP.

Culture & Benefits

• Regular employment in a manufacturing-based quality control function.
• Cross-functional collaboration with Analytical Development, QC, QA, and customer teams.
• Work supporting therapies transitioning from early clinical phases toward commercial manufacturing.