Position Responsibilities:
- 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.
Candidate Requirements:
- 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.
Preferred Experience:
- 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.
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What We Do
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.
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