Scholar Rock

Senior Director, Drug Product External Manufacturing

Scholar Rock

full-time

Posted on:

Location Type: Hybrid

Location: Cambridge • Massachusetts • United States

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Salary

💰 $245,000 - $330,000 per year

Job Level

Senior

About the role

  • 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.

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.
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
manufacturing strategiesdrug product manufacturingproject managementbudget managementvendor performance metricscontract negotiationcontinuous improvementquality assuranceregulatory complianceGMP
Soft Skills
leadershipcollaborationinfluenceteamworkrelationship buildingaccountabilityexecutioncommunicationproblem-solvingstrategic decision-making