Director, MSAT API Lead
On-siteZug, Zug, Switzerland
Zug, Zug, SwitzerlandOn-siteFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Own end-to-end technical oversight of API supply performance and continuity across external manufacturing. Establish API technical governance with CMOs focused on process robustness, performance monitoring, and elimination of recurring supply-impacting issues. Coordinate with CMC and Quality to execute tech transfers, ensuring readiness criteria, milestones, and risks are actively managed. Lead technical triage and input to deviations, investigations, and CAPAs with clear root cause and prevention actions. Assess technical and compliance impacts of process, material, and site changes while maintaining inspection-ready documentation.
Required Qualifications
- BS+ Engineering / Science (or related)
- 12–15 years MSAT / process engineering / CMC support for API (CMOs)
- Demonstrated technical issue resolution leadership and documentation rigor
Desired Qualifications
- Experience in pharmaceutical / biotech GMP manufacturing and supporting CMO audits / inspections (preferred)
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