Job Description
Senior Associate, Global External Manufacturing works to ensure 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.
Responsibilities:
- Responsible within Global External Manufacturing to execute the network strategy.
- Responsible for tactical 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.
- Responsible for coordination of inter- and intra-company technical transfers. Partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)
- 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
- Enables 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 with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch and routine supply, and then to sunset or divestiture
Basic Qualifications:
- BA or BS degree in science or engineering and 5+ years of progressively responsible experience in a pharmaceutical/biotech organization. OR MS or MBA degree may be substituted for 2 years of relevant experience
- Experience in drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
- Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
Preferred Qualifications:
- Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
- Knowledge of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus
- Ability to travel internationally, including overnight up to 20% of the time is required
- Exceptional verbal and written communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations.
