Job Title: Contract Manufacturing Site Manager
Location: Foster City Hybrid
Duration: 12 months
Job Description:
Responsible within Global External Manufacturing to support the oversight of Gilead Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
Proactively and effectively work with other Gilead functions (Quality Assurance, Quality Control, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management) to execute on manufacturing strategy.
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 complex 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.
Required Years of Experience: 15+
Top 3 Required Skill Sets: GMP Manufacturing expertise in commercial Biologics Drug Substance, Communication (written and verbal), Decision making (prioritization, risk evaluation)
Top 3 Nice to Have Skill Sets : Drug Product expertise, Technology Transfers, Clinical product manufacturing
Unique Selling Point of this role: “Highly impactful role contributing to the advancement of innovative and transformative therapies.
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