Vice President, CMC Technical Development

Job Description

Job Description

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 :

Scholar Rock is entering a pivotal phase of growth as it prepares for the global launch of its first commercial biologic product while advancing a pipeline of innovative therapies. We are seeking a highly experienced and scientifically grounded Vice President, CMC Technical Development to lead and scale our CMC development organization across early-stage, late-stage, and commercial programs.

Reporting to the Chief Technical & Quality Officer (CTO / CQO), the VP, CMC Technical Development will own end-to-end technical leadership across Drug Substance (DS), Drug Product (DP), Analytical Development, Cell Line Development, and device-enabled formulation development. This role will also be accountable for establishing and overseeing Manufacturing Science & Technology (MS&T) capabilities to ensure successful process validation, tech transfer, and ongoing support for commercial manufacturing.

Scholar Rock is translating innovative science into meaningful therapies for patients. With a growing pipeline and our first commercial product on the horizon, this is a unique opportunity to shape the technical foundation of a company at the intersection of scientific excellence and real-world impact.

Position Responsibilities :

• Strategic and Technical Leadership :
• Define and lead Scholar Rock’s CMC development strategy across all stages of the pipeline, from preclinical through commercial.
• Establish clear technical standards for molecule development, formulation, analytical control strategies, and process scalability.
• Drive CMC planning for global regulatory submissions (INDs, BLAs, MAAs), including technical content for Module 3, comparability strategies, and direct support for regulatory inspections.
• Functional Oversight :
• Drug Substance Development : Lead upstream and downstream process development, scale-up, and characterization to support early- and late-stage programs.
• Cell Line Development : Oversee development, characterization, and banking of production cell lines to support robust, scalable manufacturing.
• Analytical Development : Drive method development, qualification, validation, and analytical lifecycle management to support product quality and regulatory filings.
• Drug Product & Formulation Development : Guide formulation design for IV and SubQ delivery, including high-concentration, device-compatible presentations.
• MS&T / Process Engineering : Build a best-in-class MS&T function to support technology transfer, process validation, and lifecycle management.
• Stage 3 Process Validation & CPV : Ensure robust design and execution of Stage 1–3 validation, including CPV strategy and implementation in alignment with FDA and EMA guidance.
• CMC Innovation : Champion technology platforms, modeling, and digital tools to enhance development speed, robustness, and cost-effectiveness.
• Organizational & Cross-Functional Leadership :
• Build and lead a high-performing CMC development team, including technical project leaders, scientists, engineers, and MS&T experts.
• Collaborate closely with Regulatory, Quality, Supply Chain, Clinical, and Research to ensure technical alignment and execution across all programs.
• Serve as a core member of program governance and portfolio decision-making bodies.

Candidate Requirements :

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