Senior Manager, Global External Manufacturing- Sterile DP & Biologics
Gilead Sciences
August 11, 2026
On-site
San Francisco Bay Area
Operations
Senior Manager, Global External Manufacturing (based at the Gilead Foster City campus)
Functions / Responsibilities:
- Execute tactical manufacturing strategy and technical/operational activities to maintain clinical/commercial supply via external resources.
- Own technical lifecycle management for commercial products (intra/inter technology transfer, scale-up, process validation, continuous process validation).
- Provide parenteral manufacturing unit expertise: thawing, compounding, filtration, aseptic filling, lyophilization, capping, terminal sterilization, visual inspection, sterility assurance.
- Co-lead commercialization at external partners and support process development.
- Lead/coordinate the cross-functional CxO team; lead site activities (timelines, issue resolution, on-site troubleshooting; may negotiate limited-scope pricing).
- Lead deviations investigations and CAPAs.
- Define/review master batch records and change controls.
- Coordinate IQ/OQ/PQ and execute PV; write/review/approve validation/technical reports.
- Develop/maintain technical database for CMO technical materials; provide senior management updates.
- Serve as manufacturing representative for CMC; author/review regulatory filings technical sections.
- Train and mentor junior team members.
Experience:
- Sterile drug product manufacturing and supply chain execution/oversight.
- Supply risk management.
- cGMP manufacturing principles application.
- Worldwide regulatory knowledge (including ICH).
- Understanding of CMO landscape; CMO bulk drug substance capability knowledge is a plus.
Requirements:
- 8+ years (BA/BS) OR 6+ years (MS) OR 2+ years (PhD) in science/engineering with pharma/biotech progressive responsibility.
- Strong verbal/written communication, organization/time management, ability to manage multiple priorities.
- Working knowledge of GMPs and associated regulations; may support QA in audits.
- Ability to interact with senior management; international travel up to 10%.
People leader accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (explicitly stated): Salary range $157,590.00–$203,940.00; may include discretionary annual bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Functions / Responsibilities:
- Execute tactical manufacturing strategy and technical/operational activities to maintain clinical/commercial supply via external resources.
- Own technical lifecycle management for commercial products (intra/inter technology transfer, scale-up, process validation, continuous process validation).
- Provide parenteral manufacturing unit expertise: thawing, compounding, filtration, aseptic filling, lyophilization, capping, terminal sterilization, visual inspection, sterility assurance.
- Co-lead commercialization at external partners and support process development.
- Lead/coordinate the cross-functional CxO team; lead site activities (timelines, issue resolution, on-site troubleshooting; may negotiate limited-scope pricing).
- Lead deviations investigations and CAPAs.
- Define/review master batch records and change controls.
- Coordinate IQ/OQ/PQ and execute PV; write/review/approve validation/technical reports.
- Develop/maintain technical database for CMO technical materials; provide senior management updates.
- Serve as manufacturing representative for CMC; author/review regulatory filings technical sections.
- Train and mentor junior team members.
Experience:
- Sterile drug product manufacturing and supply chain execution/oversight.
- Supply risk management.
- cGMP manufacturing principles application.
- Worldwide regulatory knowledge (including ICH).
- Understanding of CMO landscape; CMO bulk drug substance capability knowledge is a plus.
Requirements:
- 8+ years (BA/BS) OR 6+ years (MS) OR 2+ years (PhD) in science/engineering with pharma/biotech progressive responsibility.
- Strong verbal/written communication, organization/time management, ability to manage multiple priorities.
- Working knowledge of GMPs and associated regulations; may support QA in audits.
- Ability to interact with senior management; international travel up to 10%.
People leader accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (explicitly stated): Salary range $157,590.00–$203,940.00; may include discretionary annual bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.