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.