Manager, Drug Product, Commercial Manufacturing
Listed on 2026-10-31
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Pharmaceutical
Validation Engineer, Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Quality Engineering -
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Quality Engineering
Role:
Oversee technical transfer, qualification, and lifecycle management for commercial drug products, focusing on specialized solid-dose operations including spray-dried dispersions, granulation, and coating.
manage CMO site performance, assess manufacturing capability, execute process transfers, qualification, validation, and ongoing process verification. Support post-approval changes, process improvements, deviations, investigations, and compliance readiness through cross-functional collaboration with Quality, Supply Chain, and Regulatory teams.
RequirementsBachelor’s or Master’s in Pharmaceutical Sciences, Chemical or Biochemical Engineering, with 6–8 years of pharma/biotech industry experience. Proven expertise in commercial drug manufacturing, process validation, equipment qualification, and cGMP compliance. Preferred skills include experience managing external CMOs, strong technical oversight, and risk assessment capabilities.
High Valuefocus on solid oral dose manufacturing, particle-engineering (SDD), process validation, lifecycle management, cGMP compliance, and cross-functional collaboration.
Work Setupon-site at Redwood City, CA with willingness to travel.
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