Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - GMP

Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - GMP

United States - California - Foster City | Process/Product Development & Operations | Regular

The Scientist, Cell Culture Process Development (Pre-Pivotal) will lead and execute cell culture process development for Gilead biologics entities during pre-pivotal phases (pre-clinical, phase I/II), including experimental design, laboratory execution, and process transfer. He/she will also lead and execute laboratory experimentation for cell culture process technology development, platform process evolution initiatives, and will support implementation in internal and external GMP facilities.

• Plan and execute cell culture process development laboratory studies and support process implementation in internal and external GMP facilities.
• Provide technical support for GMP operations.
• Establish and maintain a state-of-the-art cell culture process development laboratory.
• Lead studies for cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
• Contribute to design of and conduct laboratory scale experiments; hands‑on laboratory execution is expected, including weekends.
• Maintain cell culture laboratory equipment and supplies and support general laboratory upkeep.
• Author and review experimental protocols and reports.
  
  Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
• Contribute to internal knowledge management and adhere to data protection policies.
• Collect and analyze data from laboratory experiments.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• Adhere to department budget and all training, compliance and safety requirements.
• Mentor junior team members on cell culture process development strategies and experimental design and execution.
• Participate on cross‑functional initiatives as needed.

• PhD with 0+ years OR M.S. with 4+ years OR B.S. with 6+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).

• Hands‑on laboratory operations experience including shake flask, high‑throughput bioreactor, bench scale bioreactor in parallel operation.
• Experience in pre‑pivotal stage mammalian cell culture process development and implementation in GMP facilities.
• Experience with process scale‑up to pilot and manufacturing scale equipment.
• Understanding of FDA, EMA, and ICH regulatory guidelines related to cGMP.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Demonstrated ability to collaborate and influence cross‑functionally.
• Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire).
• Understanding or experience with lab automation (e.g. Delta
  
  V, PLC), data modelling and management (e.g. ETL, relational database design, SQL), data science (e.g. time‑series forecasting, mechanistic modelling), and programming/scripting (e.g. Python, R).
• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.