Scholar Rock
Senior Director, CMC Program Lead
Scholar Rock, Cambridge, Massachusetts, United States, 02141
Senior Director, CMC Program Lead
The Senior Director, CMC Program Lead will serve as a strategic and operational leader, overseeing the execution of Scholar Rock's CMC development and manufacturing programs. This individual will drive cross-functional coordination across Process Development, Analytical Sciences, Manufacturing, Quality, and Regulatory CMC to ensure delivery of key program milestones across the lifecyclefrom early development through launch and lifecycle management. The role requires an experienced, proactive leader who thrives in a fast-paced, science-driven biotech environment. 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 13 process validation, lifecycle management, and global regulatory submissions. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
The Senior Director, CMC Program Lead will serve as a strategic and operational leader, overseeing the execution of Scholar Rock's CMC development and manufacturing programs. This individual will drive cross-functional coordination across Process Development, Analytical Sciences, Manufacturing, Quality, and Regulatory CMC to ensure delivery of key program milestones across the lifecyclefrom early development through launch and lifecycle management. The role requires an experienced, proactive leader who thrives in a fast-paced, science-driven biotech environment. 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 13 process validation, lifecycle management, and global regulatory submissions. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.