Senior Manager, MSAT
Core
Strategic and operational leadership for Manufacturing Science & Technology (MSAT) documentation, ensuring cGMP compliance across technology transfers, new product introductions, and commercial manufacturing.
Role type
Senior Manager, Technical Documentation
Builds
Controlled GMP documentation (Master Batch Records, manufacturing procedures, specifications, technical reports)
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
cGMP expertise, aseptic manufacturing knowledge, leadership, technical documentation strategy, cross-functional collaboration, regulatory compliance, process validation, change control, CAPA management, audit readiness, strategic planning
Preferred skills
Microbiology experience, equipment/systems knowledge, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Establish and govern site/segment-wide MSAT documentation strategies and standards; Lead development and lifecycle management of Master Batch Records and manufacturing procedures; Serve as technical authority for manufacturing documentation; Direct activities supporting technology transfers and process validation; Oversee documentation-related quality events and compliance metrics; Mentor and lead Technical Documentation personnel; Represent the organization in client interactions and regulatory inspections.
Seniority
Senior, hands-on IC with leadership responsibilities
