Director, Upstream MSAT & Process Development

Cambridge · CambridgeFull-Timeexecutive

OtherDevelopment

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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

OtherDevelopment

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:

We are seeking an experienced and strategic Director of Upstream MSAT and Process Development within Technical Operations (CMC) to lead our biologics upstream MSAT and process development function across early-stage, late-stage, and commercial programs. This role will support externally partnered GMP production of Scholar Rock’s clinical and commercial assets with deep manufacturing science and technology expertise. The candidate will also drive the design, scale-up, and technology transfer of drug substance processes—both internally and through a global network of CDMOs. The ideal candidate combines deep upstream technical knowledge, strong organizational leadership, and proven experience managing external collaborations and in-house teams. This role is critical to ensuring robust, scalable, processes that support clinical and commercial success.

Strategic & Functional Leadership:

Lead the CMC upstream MSAT and process development team for biologics (mAbs, fusion proteins, or similar).

Serve as the upstream processes thought leader for biologics manufacturing platforms, innovation, and process robustness.

Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness.

Technical Program Oversight:

Design and oversee upstream process development across all stages (early/IND-enabling through BLA/commercial lifecycle).

Guide scale-up, technology transfer, and validation activities across external manufacturing sites.

Enable robust process ownership and technical oversight for clinical and commercial manufacturing.

Author upstream technical reports to enable program stage progression and robust regulatory filing input.

External CDMO Management:

Manage relationships with CDMOs for upstream process development, ensuring scientific rigor, quality, and timelines.

Serve as the technical upstream lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.

Enable successful delivery of clinical and commercial product through deviation and batch record review, change control oversight, and person-in-plan support.

Organizational Development:

Build and lead a high-performing CMC upstream MSAT and process development team

Foster a culture of scientific excellence, cross-functional collaboration, and accountability.

Regulatory Support:

Author and/or review relevant CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies.

Support regulatory agency interactions, inspections, and responses to information requests.

Required:

Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.

8+ years of relevant biopharmaceutical experience encompassing both MSAT and process development functions; at least 4 years in a leadership role(s).

Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.

Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges.

Strong background in tech transfer, scale-up, and working with external CDMOs.

Experience with process ownership and technical oversight for clinical and commercial manufacturing.

Experience supporting global regulatory submissions (e.g., FDA, EMA).

Preferred:

Experience in a lean, entrepreneurial biotech environment.

Familiarity with integrated CMC program leadership or technical operations governance frameworks.