Vice President, CMC Technical Development
Cambridge, MA
Technical Operations – CMC Development /
Full-Time /
On-site
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:
- 15+ years of experience in biologics development with increasing leadership responsibility in CMC, MS&T, or related technical functions.
- Demonstrated success in leading end-to-end CMC development, including IND/IMPD, BLA/MAA filings, and commercial launch.
- Deep expertise in biologics process development (DS/DP), formulation science, analytical development, cell line development, tech transfer, and Stage 3 process validation.
- Strong working knowledge of regulatory requirements (FDA, EMA, ICH) and experience supporting global health authority interactions.
- Proven ability to build and lead cross-functional technical teams in a fast-paced biotech environment.
- Ph.D. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field is required.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
