Associate Director, MSAT API
Core
Provides site-facing MSAT leadership and technical oversight for an assigned API Contract Manufacturing Organization (CMO), monitoring performance and coordinating investigations to ensure supply continuity.
Role type
Associate Director, MSAT API Technical Oversight
Builds
Ensures inspection-ready technical documentation, knowledge management, and successful tech transfers for CMO partners.
Domain
Biopharmaceuticals / Contract Manufacturing / Process Engineering
Deliverable
client delivery
Required skills
MSAT technical oversight, CMO governance routines, technical issue resolution, tech transfer readiness tracking, change impact assessment, deviation/investigation/CAPA support, risk management, executive-level technical communication
Preferred skills
Pharmaceutical/biotech CMO audit and inspection support, multi-site partner oversight
Technologies
None explicitly stated
Responsibilities
Run technical governance routines and performance monitoring for assigned CMO; Coordinate technical issue resolution and improvement actions; Lead readiness tracking for tech transfers and lifecycle changes; Provide technical input to deviations, investigations, and CAPAs; Maintain inspection-ready documentation and knowledge management
Seniority
Senior, hands-on IC with leadership scope
