Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC

$177,905 - $230,230/Yr

Gilead Sciences - Foster City, CA

Full-time - Senior

Foster City, CA

Chemical Manufacturing

About the position

The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) at Gilead Sciences, Inc. is a pivotal role focused on leading the development and implementation of cell culture processes for biologics entities during the pre-pivotal phases of development, which include pre-clinical and phase I/II stages. This position is integral to the company's mission of advancing care for patients with life-threatening diseases by ensuring that the cell culture processes are efficient, high-quality, and compliant with Good Manufacturing Practices (GMP). The role involves not only technical expertise but also leadership in project management and collaboration across various teams. In this position, the Senior Research Scientist will be responsible for establishing and maintaining a state-of-the-art cell culture process development laboratory. This includes leading projects aimed at enhancing productivity and quality of cell culture processes, as well as ensuring that all regulatory documentation is meticulously prepared and maintained. The scientist will design and conduct laboratory-scale experiments, requiring hands-on execution and a deep understanding of cell culture technologies. The role also involves reviewing and authoring GMP and non-GMP technical documentation, supporting investigations into critical deviations, and contributing to business process improvements. Mentorship of junior team members is expected, fostering an environment of growth and development within the team. The Senior Research Scientist will also be required to travel as necessary to support technology transfers and provide oversight at external manufacturing facilities, ensuring that Gilead's high standards are upheld throughout the process development lifecycle.

Responsibilities

• Lead cell culture process development and implementation in internal and external GMP facilities.
• Establish and maintain a state-of-the-art cell culture process development laboratory.
• Lead cell culture process technology development and platform process evolution projects for increased productivity, high quality product, and speed to clinic.
• Design and conduct laboratory scale experiments; hands-on laboratory execution is expected.
• Review GMP and non-GMP technical documentation (batch records, SOPs, guidance documents, and reports).
• Ensure high-quality documentation in electronic laboratory notebooks and reports.
• Author relevant sections of regulatory filings and responses to information requests.
• Support investigations and identify root causes for critical deviations.
• Travel as required to support technology transfers and provide oversight at external manufacturing facilities.
• Contribute to business process improvements related to early-stage process development.
• 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.

Requirements

• Ph.D. with 2+ years OR M.S. with 8+ years in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering) OR B.S. with 10+ 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.

Nice-to-haves

• Experience in cell culture media development, and/or model development for upstream process development and optimization is preferred.
• 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.
• Experience with viral vaccines is a plus.
• 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.