Sr Associate, Outsourced Manufacturing

About the role

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 achieve successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle.

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.
• 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.

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).