The Vice President, CMC Technical Development will lead CMC development across various programs, ensuring strategic oversight and successful regulatory submissions, while building a high-performing team.
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.
Top Skills
Biologics
Bla
Cmc
Ema
Fda
Ind
Maa
Ms&T
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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