Educational background in Chemical Engineering, Biochemistry, Biotechnology, or related biological sciences.
10+ years of experience with a BS or MS, or 5+ years with a Ph.D.
Direct experience with monoclonal antibodies (mAbs) and CHO cell culture preferred.
Familiarity with Design of Experiments (DOE) and Quality by Design (QBD) methodologies.
Experience with high-throughput cell culture systems like Ambr 15/250 is a plus.
Strong attention to detail and ability to present findings to leadership.
Responsibilities
Drive upstream process development for biologics programs, focusing on cell culture and bioreactor processes.
Guide scale-up and technology transfer activities across external manufacturing sites.
Collaborate with external CDMOs to design and execute upstream experiments.
Work cross-functionally with various teams to advance programs from development to commercialization.
Design experiments to support manufacturing deviations and investigations.
Review manufacturing documents and troubleshoot outsourced processes as needed.
Support GMP manufacturing with on-site activities.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work on cutting-edge biologics programs.
Engagement with both internal and external scientific communities.
Potential for professional growth and development in a dynamic field.
Full Job Description
Summary of Position:
The Technical Operations Organization at Scholar Rock is seeking a scientifically accomplished and motivated scientist in the Upstream Process Development and MSAT group. The successful candidate will be responsible for developing and optimizing cell culture processes for antibody production and be comfortable working on multiple priorities at once across both development and manufacturing. Significant experience with mammalian cell culture techniques (ideally CHO cells) and bioreactor operation is required. The selected candidate will work alongside both in-house and CDMO scientists to advance existing projects through the development and product lifecycle and help start up new projects.
Position Responsibilities • Drive upstream process development activities for early- and late-stage biologics programs, including cell culture process experimental design, media and feed optimization, and bioreactor process characterization. Execute in-lab as needed and present data and recommendations to inform development direction to leadership. • Provide guidance for upstream scale-up, technology transfer, manufacturability assessments and validation activities across external manufacturing sites • Serve as a subject matter expert for external upstream process development activities, including collaborating with external CDMOs to design robust and technically sound experiments to progress Scholar Rock's development pipeline • Serve as a subject matter expert for internal upstream process development activities. Collaborate cross-functionally with Research, Analytical Development, Quality, Regulatory Affairs, and Downstream Process Development teams to advance programs from early development through commercialization • Support research, downstream process development, and assay development as needed • Design experiments and draft protocols to support critical manufacturing deviations and investigations, including internal experimental execution and studies designed for external CMO execution; support the 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 with person-in-plant activities • Author upstream technical reports to enable program stage progression and robust regulatory filing input
Candidate Requirements • Educational background in Chemical Engineering, Biochemistry, Biotechnology, or related biological Sciences • Experience in DOE, QBD development, process characterization and process validation exercises highly desired • Direct experience working with mAbs and CHO cell culture is preferred • BS or MS with 10+ years of experience, Ph.D. with 5+ years of experience • Experience with Ambr 15/250 high throughput cell culture desired • Experience with tech transfer to manufacturing preferred • Cell line development experience is a plus • Strong attention to detail and experience in summarizing and presenting results to leadership is required • Some travel required (person-in-plant)
$155,000 - $195,000 a year
About Scholar Rock Holding Corporation
Scholar Rock Holding Corporation is a clinical-stage biopharmaceutical company that focuses on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company's proprietary platform technology is based on the use of growth factor-binding proteins to selectively inhibit the activation of these signaling pathways in a variety of tissues. Scholar Rock's lead product candidate, SRK-015, is a highly specific inhibitor of the activation of the growth factor myostatin, which is involved in the regulation of muscle mass. The company is headquartered in Cambridge, Massachusetts and was founded in 2012.
