Biologics Manufacturing Technical Expert Iii

Gilead Sciences

Foster City, CA, US
Base: $126,820.00 - $164,120.00; bonus/equity: dis...
Hybrid
Single use technology (sut) systems engineering
Cgmp biologics drug substance manufacturing
Facility startup and equipment validation
This role offers a unique opportunity to design, build, and operate a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City

Job Summary

  • This role offers a unique opportunity to design, build, and operate a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City.
  • The position requires a hybrid expert who can seamlessly shift between high-level strategic design decisions and hands-on tactical GMP execution on the manufacturing floor.
  • Candidates will be responsible for translating process designs into executable SOPs, leading validation studies, and ensuring full compliance with cGMP expectations during startup and ongoing operations.

Matching Summary

This role offers a unique opportunity to design, build, and operate a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City.

Salary

Base: $126,820.00 - $164,120.00; Bonus/Equity: Discretionary annual bonus and stock-based incentives available; Benefits: Medical, dental, vision, life insurance, and paid time off

Skills & Requirements

Must-have

  • Single Use Technology (SUT) systems engineering
  • cGMP Biologics Drug Substance manufacturing
  • Facility startup and equipment validation
  • Process automation and MES/ERP experience
  • Hands-on plant floor execution in biologics

Nice-to-have

  • AI tools application for manufacturing productivity
  • Cross-functional collaboration and leadership
  • Innovative problem-solving mindset
  • Experience with digital lifecycle management
  • Health authority inspection support

Key Requirements

  • BS degree with at least 5 years of applied industry experience
  • On-the-floor experience as plant technician or front-line supervisor
  • Experience in CHO based Biologics Drug Substance process design
  • Knowledge of FDA, EMA, ICH health authority requirements

Work Rights

Not specified

Tailored Resume

Cover Letter