MSAT Staff Scientist - Process Validation & Technology Transfer

Thermo Fisher Scientific seeks a Staff Scientist to lead process validation strategy and technology transfer for biologics and viral vector programs at a Massachusetts CDMO site. The role involves owning validation lifecycle execution, regulatory compliance, and cross-functional coordination for clinical and commercial programs.

Responsibilities

• Own process validation strategy execution, lifecycle management, and regulatory compliance across clinical and commercial programs
• Author and approve validation deliverables including PPQ protocols, hold-time studies, aseptic simulations, and shipping validation
• Lead technology transfer for programs transitioning from development or client sites into GMP manufacturing
• Partner cross-functionally with Manufacturing, Quality, Engineering, and Regulatory to drive compliant validation practices
• Manage multiple concurrent program lifecycles, communicate risks to leadership, and support regulatory submissions

Requirements

• Bachelor's in Chemistry, Biochemistry, or related field with 8+ years industry experience (or Master's with 6+, or Ph.D. with 4+)
• Process validation experience in cGMP biologics or cell and gene therapy manufacturing
• Minimum 2 years in technical leadership or program-lead capacity
• Expertise in FDA, EMA, and ICH guidance including Process Validation and Q8–Q11 documents
• Proficiency with statistical methods and tools such as JMP or Minitab for validation studies
• Knowledge of viral vector manufacturing (AAV, lentiviral) across upstream and downstream processes
• CDMO experience preferred