Associate II, Outsourced Manufacturing
About The Position
The Senior Associate, Global External Manufacturing, Small Molecule Drug Substance (DS) works to support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle. This position will be based at the Gilead Foster City campus.
Requirements
- 4+ years of experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science or engineering is desirable
- An MS or MBA degree may be substituted for 1 year of relevant experience
Responsibilities
- Part of the team within Global External Manufacturing to execute the network strategy.
- Responsible for execution of the business with external manufacturing organizations, and management of supplier performance
- Effectively collaborates with functions within and external to PDM to achieve corporate, cross functional, and departmental goals
- Part of the team that influences overall performance of the network CMOs to achieve Gilead’s strategic and tactical business outcomes, including Key Performance Indicators
- Participates in coordination of inter- and intra-company technical transfers.
- Executes the regular, tactical management of CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record
- Supports the team to achieve timely resolution of issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
- Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- May represent manufacturing on one or more cross-functional Development or Commercial CMC teams
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
