Senior Director, Drug Product External Manufacturing

Position Responsibilities

• Develop and execute manufacturing strategies to support drug product manufacturing needs. 
• Lead end-to-end management of external drug product manufacturing, including planning, production, and delivery as well as execution of new projects. 
• Interface closely with each drug product CMO as the Scholar Rock primary contact, providing direction to and partnering with the CMO program manager, site leadership and business lead as appropriate.  
• Ensure CMOs meet production timelines, cost targets, and regulatory and quality standards. 
• Establish and manage partnerships with CMOs to ensure capacity, capability, and compliance with company standards (e.g., FDA, EMA, ICH guidelines). 
• Coordinate and manage CMO governance meetings, in partnership with CMO program manager and/or business lead.  
• Maintain financial responsibility for CMO spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised, and PO’s are reconciled .  
• Establish alignment of objectives and priorities in close coordination with CMC team, supply chain, quality, regulatory CMC, and other functions as needed, representing the CMO(s) in strategic decisions.  
• Drive continuous improvement initiatives across external manufacturing operations to optimize efficiency and cost-effectiveness. 
• Partner with quality teams to address deviations, CAPAs, and other quality-related issues. 
• Oversee CMO due diligence during new CMO selection to vet capabilities, risks and investments required. 
• Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Scholar Rock and the CMO comply with commitments.  

Candidate Requirements

• Bachelor’s degree in engineering, life science or related field with 15 years of relevant work experience, or advanced degree and a minimum of 12 years of work experience, and at least 8 years in a leadership role overseeing manufacturing operations with vendors and/or CMOs. 
• Strong understanding of quality and regulatory requirements for drug product biopharmaceutical manufacturing (e.g., GMP, FDA, EMA). 
• Strong leadership and an innate ability to collaborate and build relationships is critical.  
• Ability to influence senior management both internally and externally.  
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion. 
• Ability to establish and monitor vendor performance metrics and implement corrective actions, as needed. 
• Can foster a culture of collaboration, accountability, and excellence within the team. 
• Can develop and manage budgets for external manufacturing operations. 
• This position may require up to 20% travel to CMO sites as necessary.