Cell Culture Process Scientist — Pivotal & Commercial

Biopharma Asia; Foster City (CA); On-site; USD 147,000 - 190,000; Full time

Job summary

Gilead Sciences Inc. is seeking a Scientist, Cell Culture Process Development to lead pivotal and commercial processes across biologics programs. You will drive cell culture development, platform evolution, and regulatory documentation in support of BLA filings, process validation, and technology transfer.

The role requires strong hands-on experience in cell culture, statistics, and cross-functional collaboration, with potential mentoring responsibilities in a fast-paced, compliant environment.

Qualifications

• Bachelor's Degree with six years of experience
• Masters' Degree with four years of experience
• PhD/PharmD

Responsibilities

• Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.
• Lead and/or support lifecycle of pivotal activities including process risk assessment, process characterization, and BLA related documentation.
• Lead and/or support technology transfer, person-in-plant, and investigations with MSAT group.
• Design experiments and perform hands-on cell culture operations in shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel platforms.
• Provide support to pilot plant operation up to 500 L.
• Perform statistical analyses and modeling to assess process parameter criticality and control strategy.
• Author/review GMP and non-GMP documents and present in cross-functional meetings.
• Collaborate cross-functionally to achieve goals and explore novel cell culture technologies for business needs.
• May manage direct/indirect reports and mentor junior staff in a flexible, agile environment.

Skills

Cell culture

Bioprocess development

Statistics & data analyses

Regulatory documentation

Education

Bachelor's Degree

Masters' Degree

PhD/PharmD

Job description

Gilead Sciences Inc. is seeking a Scientist, Cell Culture Process Development to lead pivotal and commercial processes across biologics programs. You will drive cell culture development, platform evolution, and regulatory documentation in support of BLA filings, process validation, and technology transfer.

The role requires strong hands-on experience in cell culture, statistics, and cross-functional collaboration, with potential mentoring responsibilities in a fast-paced, compliant environment.