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 Vice President of External Manufacturing will be a strategic and operational leader responsible for overseeing Scholar Rock’s global network of Contract Development and Manufacturing Organizations (CDMOs) across drug substance (DS), drug product (DP), and finished goods. This role will lead all aspects of external manufacturing operations, ensuring quality, reliability, and scalability in alignment with Scholar Rock’s commercial and clinical development priorities.
The ideal candidate brings deep technical expertise in biologics manufacturing, strong commercial readiness experience, and a track record of building and managing high-performing teams and partnerships in complex outsourced environments.
Position Responsibilities:
- Develop and lead the external manufacturing strategy across DS, DP, and packaged/finished product to support global clinical trials and commercial supply.
- Serve as the executive leader and primary point of accountability for CDMO performance, including quality, timelines, cost, and compliance.
- Ensure reliable execution of manufacturing operations to meet PDUFA, launch, and ongoing supply needs—including campaign planning, batch release, and issue resolution.
- Partner with Quality and Regulatory to ensure GMP compliance, inspection readiness, and alignment with global regulatory expectations.
- Lead CDMO governance and relationship management, including executive-level interactions, KPIs, and escalation pathways.
- Collaborate cross-functionally with CMC Development, Quality, Supply Chain, and Regulatory to align on technical transfers, validation strategies, and lifecycle management.
- Proactively identify risks and implement mitigation plans to ensure continuity and robustness of external manufacturing operations.
- Provide strategic input into make/buy decisions, site selection, and future-state network design.
- Support business development and sourcing efforts related to manufacturing.
Candidate Requirements:
- Advanced degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related discipline (PhD preferred; MS/BS with significant experience considered).
- 15+ years of progressive leadership in biopharmaceutical manufacturing, with at least 8 years in external manufacturing or CDMO management.
- Proven experience overseeing commercial-scale biologics manufacturing and launching products in highly outsourced environments.
- Deep understanding of GMP compliance, CMC regulatory expectations, and global supply chain requirements.
- Experience managing drug substance and drug product manufacturing, including high-concentration formulations and combination products.
- Strong leadership, communication, and negotiation skills with the ability to influence across internal and external stakeholders.
- Demonstrated success in building scalable teams, leading complex projects, and driving accountability in a matrixed organization.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
