Sr. Manager- ExM MS&T- On-Site
Core
Lead technical and manufacturing operations engagements with external manufacturing partners (CMOs/CDMOs) to ensure operational excellence, product quality, and optimal product flow.
Role type
Senior Manager, External Manufacturing MS&T
Builds
External pharmaceutical manufacturing network performance and product commercialization
Domain
Biopharmaceuticals / Generics / Sterile & Injectable Manufacturing
Required skills
cGMP, Technology Transfer, Scale-up, Process Optimization, Deviation/CAPA Management, Project Management, Statistical Data Analysis, Lean Six-Sigma, pFMEA
Preferred skills
Veeva/GRIDS/Harmony TW systems knowledge, Audit/Inspection Support, Cross-functional Leadership
Technologies
Veeva, GRIDS, Harmony TW
Responsibilities
Manage relationships with CMOs/CDMOs for process development and scale-up; Monitor external manufacturing performance (quality, cost, delivery); Lead technology transfer and material transfer projects; Ensure regulatory compliance (FDA, EMA, ICH) and support audits; Troubleshoot manufacturing deviations and implement CAPAs.
Seniority
Senior Manager, hands-on IC