Senior Scientist II, Upstream Process Development and MSAT
About The Position
Scholar Rock is seeking a scientifically accomplished and motivated scientist to join its Technical Operations Organization in the Upstream Process Development and MSAT group. The role develops and optimizes cell culture processes for antibody production and supports priorities across development and manufacturing. The successful candidate will work with in-house and CDMO scientists to advance existing programs through development and the product lifecycle, and to help start new projects. Significant experience in mammalian cell culture, ideally CHO cells, and bioreactor operation is required. The position supports early- and late-stage biologics programs, including process development, scale-up, technology transfer, manufacturing troubleshooting, and GMP manufacturing. It involves cross-functional collaboration, technical oversight of external development and manufacturing activities, experimental execution, and preparation of technical reports for program progression and regulatory filings. Some travel is required for person-in-plant activities.
Requirements
- Educational background in Chemical Engineering, Biochemistry, Biotechnology, or related biological sciences.
- Bachelor’s or master’s degree with 10+ years of experience, or Ph.D. with 5+ years of experience.
- Significant experience with mammalian cell culture techniques and bioreactor operation.
- Strong attention to detail and experience summarizing and presenting results to leadership.
- Some travel required for person-in-plant activities.
Nice To Haves
- Experience in DOE, QbD development, process characterization, and process validation exercises.
- Direct experience working with monoclonal antibodies and CHO cell culture.
- Experience with Ambr 15/250 high-throughput cell culture.
- Experience with technology transfer to manufacturing.
- Cell line development experience.
Responsibilities
- Drive upstream process development for early- and late-stage biologics programs, including experimental design, media and feed optimization, and bioreactor process characterization; execute laboratory work as needed and present data and recommendations to leadership.
- Guide upstream scale-up, technology transfer, manufacturability assessments, and validation activities at external manufacturing sites.
- Serve as a subject matter expert for external upstream process development, collaborating with CDMOs to design robust, technically sound experiments.
- Serve as a subject matter expert for internal upstream process development and collaborate with Research, Analytical Development, Quality, Regulatory Affairs, and Downstream Process Development to advance programs from early development through commercialization.
- Support research, downstream process development, and assay development as needed.
- Design experiments and draft protocols for manufacturing deviations and investigations, including internal execution and studies for external CMO execution.
- Support development and implementation of future internal high-throughput bioreactor capabilities, such as AMBR.
- Review manufacturing documents and troubleshoot outsourced manufacturing processes as needed.
- Support clinical and commercial GMP manufacturing through person-in-plant activities.
- Author upstream technical reports to support program stage progression and regulatory filing input.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
