MSAT Staff Scientist - Process Validation & Technology Transfer Job at Thermo Fisher Scientific, Plainville, MA

  • Thermo Fisher Scientific
  • Plainville, MA

Job Description

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

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