Senior Director, CMC Process Development

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Cambridge, MA

Technical Operations – Process Development /

Full-Time /

On-site

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 Senior Director of CMC Process Development to lead our biologics process development function across early-stage, late-stage, and commercial programs. This role will drive the design, scale-up, and technology transfer of drug substance and drug product processes—both internally and through a global network of CDMOs. Expertise in high-concentration biologics is essential.

The ideal candidate combines deep 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.

Position Responsibilities:

- Strategic & Functional Leadership
- Lead the CMC process development strategy for biologics (mAbs, fusion proteins, or similar), including upstream and downstream development.
- Serve as the enterprise 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 process development programs across all stages (early/IND-enabling through BLA/commercial lifecycle).
- Guide scale-up, technology transfer, and validation activities across internal and external manufacturing sites.
- Drive the development of high-concentration formulations suitable for subcutaneous administration (e.g., >100 mg/mL), including associated drug product process characterization.
- External CDMO Management
- Manage and oversee relationships with CDMOs for both drug substance and drug product development, ensuring scientific rigor, quality, and timelines.
- Serve as the technical lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables.
- Organizational Development
- Build and lead a high-performing CMC process development team, including technical experts and project leaders.
- Foster a culture of scientific excellence, cross-functional collaboration, and accountability.
- Regulatory Support
- Contribute to 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.

Candidate Qualifications:

- Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field.
- 12+ years of relevant experience in biopharmaceutical process development, with at least 5 years in a leadership role.
- Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management.
- Demonstrated expertise in high-concentration biologics and associated drug product development challenges.
- Strong background in tech transfer, scale-up, and working with external CDMOs.
- Experience supporting global regulatory submissions (e.g., FDA, EMA).
- Experience in a lean, entrepreneurial biotech environment.
- Familiarity with integrated CMC program leadership or technical operations governance frameworks.
- Hands-on experience with aseptic drug product process development and container-closure systems.
- Strategic and enterprise mindset
- Deep technical expertise with strong decision-making capability
- Effective communicator with cross-functional and external partners
- Proactive, solution-oriented leadership style
- High standards of scientific rigor and compliance

$240,000 - $330,000 a year

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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