Scientist - Cell Culture Process Development (Pivotal & Commercial)

Job Description

*At a future date this position will relocate to the corporate HQ in Foster City, CA.

The Scientist, Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to 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 entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA filing, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.
• Support technology transfer 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.
• May provide support to pilot plant operation for up to 500 L single-use bioreactor.
• 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.), 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.
• Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment.

Basic Qualifications:

• Ph.D. in Chemical Engineering, Biochemistry, or related fields OR M.S. with 6+ years of relevant experience OR B.S. with 8+ years of relevant experience.
• At a future date, this position will relocate to the corporate headquarter in Foster City, CA.

Preferred Qualifications:

• Strong understanding and extensive 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. In-depth knowledge of industry best practices & trends.
• Solid understanding and experience in statistics and data analyses.
• Experience in mammalian cell culture process development and pivotal development, process characterization and commercial support of cell culture operations from seed train to production.
• Experience in process transfer to manufacturing facilities and technical leadership in process troubleshooting.
• Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post approval changes is a plus.
• Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline 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 - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Gilead Core Values:

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)