Senior Biologics Manufacturing Technical Expert
Gilead Sciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Job Description
- Lead design, startup, and operation of a new Single-Use DS biologics drug substance (cGMP) manufacturing facility in Foster City, CA (hybrid technical/execution role with on-floor presence).
- Execute and document unit operations; perform dry/engineering runs and end-to-end walkthroughs to ensure first-time execution readiness.
- Act as technical first responder during campaigns; plan/execute full-scale process and equipment validation.
- Provide manufacturing end-user input to facility/equipment/automation; support digital manufacturing/data workflow startup.
- Participate in risk assessments; translate new process requirements into equipment/automation/documentation updates.
- Improve processes to increase yield, capacity, efficiency, compliance, and safety; compliantly apply AI/digital tools to boost productivity.
- Author/review SOPs, work instructions, batch records, validation protocols/reports; initiate/support CAPAs for deviations; support QRM and health authority interactions as SME.
Basic Qualifications
- Recognized expert in Biologics Drug Substance Single-Use Manufacturing.
- BS in Science or Engineering + 6+ years technical experience in Biologics DS Manufacturing.
Additional Technical Experience (3+ areas)
- On-the-floor SU technologies experience; SUT engineering/trending.
- cGMP facility/utility/equipment commissioning, qualification, validation, operational startup.
- Risk-based cGMP controls (incl. Contamination Control Strategy).
- CHO DS process development/validation/tech transfer.
- Process automation/MES/ERP recipe design and use (examples preferred: Emerson DeltaV, PI, Ignition, Korber PAS-X, SAP).
- Digital manufacturing lifecycle/parameterization/tech transfer; practical AI/digital solutions.
- cGMP QA, QRM, plant floor oversight/auditor experience; manufacturing optimization/continuous improvement.
- Health authority/inspection knowledge (FDA/EMA/ICH); people leadership/management.
Compensation & Benefits
- Salary range: $146,540.00–$189,640.00. May include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
- Lead design, startup, and operation of a new Single-Use DS biologics drug substance (cGMP) manufacturing facility in Foster City, CA (hybrid technical/execution role with on-floor presence).
- Execute and document unit operations; perform dry/engineering runs and end-to-end walkthroughs to ensure first-time execution readiness.
- Act as technical first responder during campaigns; plan/execute full-scale process and equipment validation.
- Provide manufacturing end-user input to facility/equipment/automation; support digital manufacturing/data workflow startup.
- Participate in risk assessments; translate new process requirements into equipment/automation/documentation updates.
- Improve processes to increase yield, capacity, efficiency, compliance, and safety; compliantly apply AI/digital tools to boost productivity.
- Author/review SOPs, work instructions, batch records, validation protocols/reports; initiate/support CAPAs for deviations; support QRM and health authority interactions as SME.
Basic Qualifications
- Recognized expert in Biologics Drug Substance Single-Use Manufacturing.
- BS in Science or Engineering + 6+ years technical experience in Biologics DS Manufacturing.
Additional Technical Experience (3+ areas)
- On-the-floor SU technologies experience; SUT engineering/trending.
- cGMP facility/utility/equipment commissioning, qualification, validation, operational startup.
- Risk-based cGMP controls (incl. Contamination Control Strategy).
- CHO DS process development/validation/tech transfer.
- Process automation/MES/ERP recipe design and use (examples preferred: Emerson DeltaV, PI, Ignition, Korber PAS-X, SAP).
- Digital manufacturing lifecycle/parameterization/tech transfer; practical AI/digital solutions.
- cGMP QA, QRM, plant floor oversight/auditor experience; manufacturing optimization/continuous improvement.
- Health authority/inspection knowledge (FDA/EMA/ICH); people leadership/management.
Compensation & Benefits
- Salary range: $146,540.00–$189,640.00. May include discretionary bonus, long-term incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.