Senior Biologics Manufacturing Technical Expert
Gilead Sciences
August 25, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Are you ready to lead Gilead’s next chapter as we design and establish our biologics manufacturing footprint in Foster City, CA?
Gilead Sciences is seeking hands-on technical experts in Biologics Drug Substance Single-Use GMP Manufacturing.
Key Responsibilities:
- Own and directly execute critical elements of design, startup, and operation of a new Single Use DS Biologics manufacturing facility; alternate between strategic design decisions and hands-on GMP execution.
- Manufacturing execution/startup: support first-time execution readiness (dry runs/engineering runs/walkthroughs), act as technical first responder during campaigns, execute and document operations on the plant floor, plan and execute process/equipment validation studies, champion single-use best practices.
- Facility/equipment/process input: provide end-user input, support startup of digital manufacturing/data solutions, participate in risk assessments/startup readiness, translate process requirements into equipment/automation/documentation updates.
- Operational excellence/digital innovation: develop solutions to technical challenges; implement process improvements; apply AI tools compliantly; provide cross-functional guidance; consult to senior management; model leadership and core values.
- Documentation/quality/compliance: translate design docs into SOPs/work instructions, author/review GMP documentation, initiate/support CAPAs for deviations, support QRM, serve as SME with health authorities.
Basic Qualifications:
- Recognized expert in Biologics Drug Substance Single Use Manufacturing.
- BS in Science or Engineering + at least 6 years technical experience in Biologics DS Manufacturing.
Additional Required/Relevant Experience (choose at least 3):
- On-the-floor SUT experience as technician/supervisor in licensed Biologics DS facility.
- cGMP facility/process/utilities/equipment design, commissioning/qualification, validation, and operational startup.
- SUT systems engineering design/selection/use/performance trending.
- Risk-based cGMP controls/Contamination Control Strategy.
- CHO-based DS process design/development/validation/tech transfer (lab/pilot to manufacturing/among sites).
- Automation/controls/MES/ERP recipe design and use; digital manufacturing lifecycle/parameterization.
- Practical AI/digital solutions for measurable efficiency.
- Quality assurance in cGMP biologics; QRM/QA oversight.
- Manufacturing optimization/continuous improvement.
- GMP proficiency development.
- Health Authority (FDA/EMA/ICH) requirements/inspections.
- People leadership/management.
Compensation & Benefits:
- Salary range: $146,540.00 - $189,640.00. May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences is seeking hands-on technical experts in Biologics Drug Substance Single-Use GMP Manufacturing.
Key Responsibilities:
- Own and directly execute critical elements of design, startup, and operation of a new Single Use DS Biologics manufacturing facility; alternate between strategic design decisions and hands-on GMP execution.
- Manufacturing execution/startup: support first-time execution readiness (dry runs/engineering runs/walkthroughs), act as technical first responder during campaigns, execute and document operations on the plant floor, plan and execute process/equipment validation studies, champion single-use best practices.
- Facility/equipment/process input: provide end-user input, support startup of digital manufacturing/data solutions, participate in risk assessments/startup readiness, translate process requirements into equipment/automation/documentation updates.
- Operational excellence/digital innovation: develop solutions to technical challenges; implement process improvements; apply AI tools compliantly; provide cross-functional guidance; consult to senior management; model leadership and core values.
- Documentation/quality/compliance: translate design docs into SOPs/work instructions, author/review GMP documentation, initiate/support CAPAs for deviations, support QRM, serve as SME with health authorities.
Basic Qualifications:
- Recognized expert in Biologics Drug Substance Single Use Manufacturing.
- BS in Science or Engineering + at least 6 years technical experience in Biologics DS Manufacturing.
Additional Required/Relevant Experience (choose at least 3):
- On-the-floor SUT experience as technician/supervisor in licensed Biologics DS facility.
- cGMP facility/process/utilities/equipment design, commissioning/qualification, validation, and operational startup.
- SUT systems engineering design/selection/use/performance trending.
- Risk-based cGMP controls/Contamination Control Strategy.
- CHO-based DS process design/development/validation/tech transfer (lab/pilot to manufacturing/among sites).
- Automation/controls/MES/ERP recipe design and use; digital manufacturing lifecycle/parameterization.
- Practical AI/digital solutions for measurable efficiency.
- Quality assurance in cGMP biologics; QRM/QA oversight.
- Manufacturing optimization/continuous improvement.
- GMP proficiency development.
- Health Authority (FDA/EMA/ICH) requirements/inspections.
- People leadership/management.
Compensation & Benefits:
- Salary range: $146,540.00 - $189,640.00. May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions:
- For current Gilead employees and contractors, apply via the Internal Career Opportunities portal in Workday.