Senior Director, CMC Program Lead

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

The Senior Director, CMC Program Lead will serve as a strategic and operational leader, overseeing the execution of Scholar Rock’s CMC development and manufacturing programs. This individual will drive cross-functional coordination across Process Development, Analytical Sciences, Manufacturing, Quality, and Regulatory CMC to ensure delivery of key program milestones across the lifecycle—from early development through launch and lifecycle management. The role requires an experienced, proactive leader who thrives in a fast-paced, science-driven biotech environment.

• Serve as the CMC Program Lead for key pipeline assets and commercial products, ensuring integrated planning, execution, and governance across internal and external functions.
• Lead cross-functional CMC program teams, aligning timelines, deliverables, and risk mitigation strategies across drug substance, drug product, device, packaging, and supply chain.
• Drive development and execution of CMC plans in support of IND, BLA/MAA submissions, and global launches, ensuring alignment with regulatory requirements and commercial readiness.
• Partner closely with Process Development and Manufacturing teams to oversee technical transfer, process validation, and comparability planning.
• Maintain accountability for CMC timelines, budget, resource planning, and key deliverables.
• Serve as the primary interface between CMC and program leadership, translating technical strategy into executable operational plans.
• Facilitate technical governance meetings, decision-making forums, and stage-gate readiness reviews.
• Support regulatory strategy development and health authority interactions as the CMC lead contributor.

• Advanced degree (PhD preferred, MS/BS considered with strong experience) in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline.
• 12+ years of experience in biopharmaceutical CMC development with a focus on biologics.
• Proven experience leading cross-functional CMC programs from IND through BLA and into commercialization.
• Deep understanding of process development, tech transfer, GMP manufacturing, and regulatory expectations for biologics, including high-concentration and subcutaneous formulations.
• Strong program management skills with the ability to anticipate and mitigate CMC risks.
• Excellent communication, leadership, and interpersonal skills; capable of influencing at all levels.

• Experience with high-concentration biologic formulations and combination product development.
• Prior exposure to working with CDMOs and managing complex external partnerships.
• Familiarity with Stage 1–3 process validation, lifecycle management, and global regulatory submissions.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.