Gilead Sciences, Inc.
Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Developm
Gilead Sciences, Inc., Foster City, California, United States, 94420
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.
Key Responsibilities
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.
Basic Qualifications / Experience
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).
Preferred Qualifications / Skills / Experience
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. DeltaV, 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.
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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.
Key Responsibilities
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.
Basic Qualifications / Experience
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).
Preferred Qualifications / Skills / Experience
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. DeltaV, 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.
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