Overview
Hybrid2 days onsite and 3 days remote
$70 - $88
Contract - W2
Contract - 12 Month(s)
Skills
Manufacturing
Drug
GMP
Job Details
One of our direct BioPharmaceutical client is looking to hire Operations Manager (Drug Manufacturing Site Manager) at Foster City, CA.
This is Hybrid, 2 days onsite at Foster City CA and 3 days Remote.
Job Description:
- Responsible within Global External Manufacturing to support the oversight of Client's Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
- Proactively and effectively work with other 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.
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.
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