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 optimizing and characterizing cell culture processes for pivotal trials and commercialization, contributing to lifecycle activities such as process risk assessment, process characterization, BLA documentation and filing, and process performance qualifications. It includes experimental design and hands-on cell culture work across a range of scales and platforms, support for pilot plant operations up to 500 L, technology transfer and investigation work with MSAT, statistical analysis and modeling, and authoring and reviewing technical documents. The position may manage direct and indirect reports and mentor junior team members.
Requirements
- Bachelor's degree and six years of experience, or master's degree and four years of experience, or Ph.D./Pharm.D.
- Strong understanding 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.
- Hands-on laboratory operations experience with shake flasks, high-throughput bioreactors, bench-scale bioreactors, or pilot-scale cultures.
- Solid understanding of and experience with statistics and data analysis.
- Motivated 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.
- Working knowledge of industry best practices and trends.
- 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, 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 perform hands-on cell culture operations using shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.
- Support pilot plant operations for 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.
- Participate in cross-functional work 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.
Benefits
- May be eligible for a discretionary annual bonus.
- May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
