Knowledge of pharmaceutical gmps and ich guidelines
The role involves executing the tactical management of Contract Manufacturing Organizations (CMOs) to ensure Oral Solid Dose products meet registered processes
Job Summary
The role involves executing the tactical management of Contract Manufacturing Organizations (CMOs) to ensure Oral Solid Dose products meet registered processes.
Candidates must possess strong working knowledge of pharmaceutical GMPs and ICH regulatory guidance to handle complex manufacturing issues and deviations.
Gilead offers a competitive salary range of $182,070.00 - $235,620.00 along with discretionary bonuses and comprehensive benefits packages.
Matching Summary
The role involves executing the tactical management of Contract Manufacturing Organizations (CMOs) to ensure Oral Solid Dose products meet registered processes.
Salary
Base: $182,070.00 - $235,620.00; Bonus/Equity: Discretionary annual bonus and stock-based incentives available; Benefits: Medical, dental, vision, life insurance, and paid time off
Skills & Requirements
Must-have
10+ years managing external sites
Bachelor's degree in Chemistry or Engineering
Knowledge of pharmaceutical GMPs and ICH guidelines
Experience with CMO landscape and vendor management
Ability to negotiate competitive costs
Nice-to-have
OSD drug product manufacturing experience
Worldwide regulatory requirements knowledge
Supporting regulatory inspections and audits
Advanced expertise in supplier performance management
Key Requirements
Bachelor's degree with 10+ years experience OR Master's with 8+ years
Proven experience managing external suppliers and logistics providers
Demonstrated ability to interact with senior management