Scientist, Process Development
About The Position
The Scientist, Cell Culture Process Development (Pivotal & Commercial) leads aspects of cell culture development, including commercial process development and process characterization for biologics programs during pivotal phases (Phases II/III and post-launch). The role also leads projects in cell culture process technology development and platform process evolution, and supports cell culture-related regulatory documentation. The position involves developing and characterizing processes for monoclonal antibodies, multi-specifics, and novel modalities; supporting pivotal activities through BLA filing and process performance qualification; and partnering with global manufacturing sciences and technologies on technology transfer, investigations, and person-in-plant activities. The Scientist performs hands-on cell culture work at laboratory and pilot scales, conducts statistical analyses and modeling, authors and reviews technical and regulatory documents, and collaborates across functions. The role may manage direct and indirect reports and mentor junior team members. The listed salary range is $146,540 to $189,640. The position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance, subject to applicable plan terms and eligibility.
Requirements
- Bachelor's degree and six years of experience, or a master's degree and four years of experience, or a PhD/PharmD.
- Strong understanding of and hands-on experience in cell culture process development.
- In-depth knowledge of mammalian cell culture processes, including molecular biology and cell engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, and single-use and stainless-steel bioreactor systems.
- Working knowledge of industry best practices and trends.
- Hands-on laboratory operations experience with shake flasks, high-throughput bioreactors, bench-scale bioreactors, or pilot-scale cultures.
- Solid understanding of and experience in statistics and data analysis.
- Motivation and ability to work as a self-starter, with excellent interpersonal and organizational skills.
- Excellent verbal communication, oral presentation, and scientific writing skills.
Nice To Haves
- Ph.D. with 0–2 years of relevant experience.
- Basic knowledge of FDA, EMA, and ICH guidelines relating to registration, quality, and compliance for drug substance.
- Experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post-approval changes.
Responsibilities
- Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.
- Lead or support pivotal activities across their lifecycle, including process risk assessment, process characterization, preparation of supporting documentation and reports for BLA filing, support for process performance qualifications (PPQ), and authorship of relevant BLA sections.
- Lead or support technology transfer, person-in-plant, and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.
- Design experiments and conduct hands-on cell culture operations using shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.
- Support pilot plant operations at scales up to 500 L.
- Perform statistical analyses and modeling to assess process parameter criticality, identify acceptable ranges, and contribute to an integrated control strategy.
- Author and review GMP and non-GMP technical documents, including reports, regulatory filings and responses, batch records, and SOPs; present in group and cross-functional meetings.
- Collaborate cross-functionally to achieve shared goals.
- Explore, develop, and implement novel cell culture technologies to meet business needs.
- May manage direct and indirect reports and mentor junior group members.
- As a people leader, create inclusion, develop talent through coaching and feedback, and empower teams by aligning goals and removing barriers.
Benefits
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentive eligibility
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
