MSAT Lead 80-100%
Core
Lead MSAT team through CAPEX growth project ramp-up, driving PPQs, aseptic process simulations, and equipment qualifications for sterile fill & finish lines.
Role type
Senior MSAT Team Lead (Sterile Fill & Finish)
Builds
Sterile fill & finish manufacturing lines and processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MSAT operations, sterile fill & finish manufacturing, technology transfer, process implementation, performance management, root cause analysis, regulatory inspection readiness, lifecycle process support
Preferred skills
Lyophilization, ADCs, natural sciences degree
Technologies
Single-use technologies, process monitoring, continued process verification
Responsibilities
Lead MSAT organization for facility ramp-up and process implementation; Own technical implementation and qualification strategy ensuring GMP compliance; Ensure inspection readiness and represent during regulatory audits; Partner with Operations and Engineering for strategic priorities; Collaborate across functions for seamless technology transfers; Establish and improve MSAT standards and risk-based approaches; Lead complex product and process investigations and CAPAs.
Seniority
Senior, hands-on IC with people leadership
