Senior Director, Drug Product External Manufacturing

Cambridge · CambridgeFull-Timesenior

OtherManufacturing

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Quick Summary

Overview

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need.

Technical Tools

OtherManufacturing

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:

Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product External Manufacturing to lead drug product external manufacturing for our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. In this role you will lead and oversee all drug product manufacturing operations managed through external contract manufacturing organizations (CMOs). This role is critical in ensuring the seamless production, quality, and delivery of clinical and commercial products, aligning with company goals and regulatory standards. The ideal candidate will possess deep expertise in biopharmaceutical manufacturing, strategic leadership, and a strong ability to manage complex global operations.

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.

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.