Biologics Manufacturing Technical Expert III
Gilead Sciences
June 26, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Role: Hands-on technical expert for Biologics Drug Substance Single-Use GMP Manufacturing; hybrid strategy + execution supporting design, startup, and cGMP operations of a new Single Use DS manufacturing facility in Foster City, CA.
Responsibilities:
- Support first-time execution readiness (dry runs, engineering runs, end-to-end walkthroughs) before GMP go-live.
- Act as technical first responder during campaigns; stabilize operations and resolve issues in real time.
- Execute/document key plant-floor operations in full cGMP compliance; perform full-scale process and equipment validation.
- Provide end-user input to facility/equipment/automation design; support startup workflow development for digital manufacturing/data solutions.
- Participate in risk assessments and startup readiness for equipment/process/workflows.
- Develop/pragmatically apply process improvements (yield, capacity, efficiency, cost, compliance, safety), and apply AI tools for productivity.
- Author/review GMP documentation (SOPs, work instructions, batch records, training, validation protocols/reports); initiate/support CAPAs; participate in QRM.
Basic Qualifications:
- BS with at least 5 years applied industry experience.
- Applied experience across at least two listed areas (e.g., single-use DS manufacturing; cGMP facility commissioning/validation/startup; SUT systems; risk-based controls/contamination control strategy; CHO DS development/tech transfer; automation/MES/ERP; digital manufacturing; AI in pharma ops; QA/QRM oversight; continuous improvement; GMP proficiency development; FDA/EMA/ICH inspections).
Benefits/Compensation (as stated): $126,820–$164,120 base; may include bonus/stock incentives, PTO, and medical/dental/vision/life insurance.
Application: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Support first-time execution readiness (dry runs, engineering runs, end-to-end walkthroughs) before GMP go-live.
- Act as technical first responder during campaigns; stabilize operations and resolve issues in real time.
- Execute/document key plant-floor operations in full cGMP compliance; perform full-scale process and equipment validation.
- Provide end-user input to facility/equipment/automation design; support startup workflow development for digital manufacturing/data solutions.
- Participate in risk assessments and startup readiness for equipment/process/workflows.
- Develop/pragmatically apply process improvements (yield, capacity, efficiency, cost, compliance, safety), and apply AI tools for productivity.
- Author/review GMP documentation (SOPs, work instructions, batch records, training, validation protocols/reports); initiate/support CAPAs; participate in QRM.
Basic Qualifications:
- BS with at least 5 years applied industry experience.
- Applied experience across at least two listed areas (e.g., single-use DS manufacturing; cGMP facility commissioning/validation/startup; SUT systems; risk-based controls/contamination control strategy; CHO DS development/tech transfer; automation/MES/ERP; digital manufacturing; AI in pharma ops; QA/QRM oversight; continuous improvement; GMP proficiency development; FDA/EMA/ICH inspections).
Benefits/Compensation (as stated): $126,820–$164,120 base; may include bonus/stock incentives, PTO, and medical/dental/vision/life insurance.
Application: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.