Senior Engineer II, Downstream Manufacturing Science & Technology; MSAT

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the 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 Rockworks every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at  and follow @Scholar Rock on X and on Linked In.

Scholar Rock is seeking a Senior Engineer II, Downstream Manufacturing Science & Technology (MSAT), to provide technical leadership for monoclonal antibody downstream manufacturing across a global external manufacturing network. This role serves as the downstream process SME supporting commercial manufacturing, technology transfer, PPQ/process validation, CPV, investigations, change control, regulatory support, and lifecycle management.

The ideal candidate brings strong downstream biologics process expertise, significant GMP manufacturing experience, sound technical judgment, and the ability to partner effectively with CDMOs and internal Process Development, External Manufacturing, Quality, Regulatory, and Supply Chain teams. This role is expected to influence cross-functional decision-making and serve as a trusted technical partner across downstream manufacturing activities.

• Provide downstream process oversight for late-stage clinical and commercial manufacturing at CDMOs, including campaign readiness, technical risk assessment, manufacturing planning, and execution support.
• Serve as Person-in-Plant, as needed, for technology transfer, PPQ/process validation, and clinical/commercial manufacturing activities.
• Provide timely technical support during critical manufacturing operations, including off-hours support when required.

• Own and maintain process monitoring systems, manufacturing databases, lot histories, and CPV programs.
• Analyze manufacturing performance through statistical trending and process monitoring tools to ensure processes remain in a state of control.
• Support Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and ongoing commercial lifecycle management activities including post-approval changes and continuous improvement initiatives.

• Collaborate with Process Development teams to ensure effective transfer of process knowledge into GMP manufacturing operations.
• Support or lead process characterization, process performance qualification (PPQ), and process validation activities.
• Contribute to generation and execution of validation protocols, validation reports, and associated technical documentation.

• Lead or support deviations, atypical results, process excursions, change controls, technical/risk assessments, CAPAs, and issue resolution for downstream manufacturing processes.
• Present technical analyses, manufacturing trends, and process performance updates to cross-functional teams and leadership.

• Review and author GMP manufacturing documentation, batch records, technical reports, , and regulatory submission content.
• Support health authority responses,…