Scientist, Process Development

About the Role

At Gilead, we are dedicated to creating a healthier world by developing life-changing therapies for significant diseases. We seek passionate and ambitious individuals ready to make a direct impact.

Job Description

The Scientist, Cell Culture Process Development (Pivotal & Commercial) will lead aspects of cell culture development, including commercial process development and process characterization for biologics programs during pivotal phases (phases II/III and post-launch). This role will also lead projects for cell culture process technology development, platform process evolution, and support cell culture-related regulatory documentation.

Key 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 the entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of supporting documentation/reports for BLA filing, support for successful process performance qualifications (PPQ), and authoring relevant sections of BLA.
• Lead and/or support technology transfer, person-in-plant, and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.
• Design experiments and perform hands-on cell culture operations in shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.
• Provide support to pilot plant operation for up to 500 L.
• Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy.
• Author and review GMP and non-GMP technical documents (reports, regulatory filings/responses, batch records, SOPs, etc.) and present in group/cross-functional meetings.
• Participate and work cross-functionally to achieve common goals.
• Explore, develop, and implement novel cell culture technologies to meet business needs.
• May manage direct and indirect reports and mentor junior group members in a flexible and agile environment.

Requirements & Tech Stack

• Bachelor's Degree and Six Years' Experience OR Master's Degree and Four Years' Experience OR PhD/PharmD

Preferred Qualifications

• Ph.D. with 0-2 years of relevant experience.
• Strong understanding and hands-on experience in cell culture process development.
• In-depth knowledge of mammalian cell culture processes including molecular biology & cell engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, single use and stainless bioreactor systems.
• Working knowledge of industry best practices & trends.
• Hands-on laboratory operations experience including shake flasks, high-throughput bioreactors, bench scale bioreactors, or pilot scale cultures.
• Solid understanding and experience in statistics and data analyses.
• Basic knowledge of FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance.
• Experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post approval changes is a plus.
• Motivated self-starter with excellent interpersonal and organizational skills.
• Excellent verbal communication, oral presentation, and scientific writing skills.

People Leader Accountabilities

• Create Inclusion: Understand the business value of diverse teams, model inclusion, and embed diversity in team management.
• Develop Talent: Understand employee skills, experience, aspirations, and potential; coach on current performance and future potential; provide feedback for growth and purpose realization.
• Empower Teams: Connect the team to the organization by aligning goals, purpose, and objectives; hold teams accountable; provide support to remove barriers and connect the team to the broader ecosystem.