Sobre esta vaga de Senior Scientist II, Upstream Process Development and MSAT na Scholarrock
Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Position Responsibilities
• 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
• 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)
