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

$143,225 - $185,350/Yr

1010 Gilead Sciences, Inc. - Foster City, CA

Full-time - Entry Level

Foster City, CA

About the position

The Senior Associate Scientist, Cell Culture Process Development (Pre-Pivotal) at Gilead will lead and execute laboratory experimentation for cell culture process development during the pre-pivotal phases of biologics entities. This role involves establishing a state-of-the-art laboratory, providing technical support for GMP operations, and mentoring junior team members. The position is critical in contributing to the development of life-changing therapies and ensuring high-quality product delivery.

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.
• Author and review experimental protocols and reports.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and reports.
• 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.

Requirements

• 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, and pilot scale cultures.
• Experience in pre-pivotal stage cell culture process development and implementation in GMP facilities.
• 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).
• Working knowledge of lab automation, data management, data science, knowledge management and data protection.
• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.