Lead a team of professionals to provide validation services for systems associated with the manufacture of active pharmaceutical ingredient (API) drug substance
Job Summary
Lead a team of professionals to provide validation services for systems associated with the manufacture of active pharmaceutical ingredient (API) drug substance.
Establish compliant validation strategies and procedures to align with Amgen operation standards and regulatory expectation.
Represent validation and manufacturing execution for regulatory inspections and filings, audits.
Matching Summary
Lead a team of professionals to provide validation services for systems associated with the manufacture of active pharmaceutical ingredient (API) drug substance.
Skills & Requirements
Must-have
API drug substance manufacturing
validation strategies and procedures
risk-based and science-based approach
regulatory inspections
cGMP and safety requirements
cross functional interactions
Nice-to-have
champion cultural transformation
drive employee engagement activities
advocate and drive safety and quality culture
Key Requirements
Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience
2 years of managerial experience
8+ years experience in commercial drug operations
5+ years managing a team
2+ years project management experience
2+ years operations/technical experience in pharmaceutical industry