Senior Associate, Global External Manufacturing (based at Gilead Foster City campus)
Responsibilities:
- Execute Global External Manufacturing network strategy.
- Tactical execution with external manufacturing organizations; manage supplier performance.
- Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal sites for successful technology transfer/validation to identified CMOs.
- Manage CMOs to ensure products are manufactured per registered process and approved Master Production Record.
- Resolve manufacturing/compliance issues: deviations, out-of-spec investigations, Material Review Board investigations, finished product trending, and change control.
- Drive continuous improvement to reduce cost, improve quality/efficiency, and ensure sustainability.
- Represent manufacturing on cross-functional Development/Commercial CMC teams across product lifecycle (clinical to launch to routine supply to sunset/divestiture).
Basic Qualifications:
- BA/BS in science or engineering + 5+ years progressive pharma/biotech experience; or MS/MBA substituting 2 years relevant experience.
- Experience in drug product manufacturing and supply chain execution/oversight.
- Understanding/application of cGMP.
Preferred Qualifications:
- Knowledge of worldwide regulatory requirements, including ICH.
- CMO landscape knowledge (plus).
- International travel (overnight) up to 20%.
- Exceptional verbal/written communication with senior leaders and CMOs.
Compensation/Benefits (as stated): Salary range $117,895.00β$152,570.00; may be eligible for discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions (for current employees/contractors): Apply via the Internal Career Opportunities portal in Workday.