The Senior Director of CMC Process Development leads biologics process development, overseeing strategy, technical programs, external partnerships, and regulatory support. Must have expertise in biologics and management experience.
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 processes—both internally and through a global network of CDMOs. Expertise with drug substance process development for 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.
Key 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 external manufacturing sites.
- Enable robust process ownership and technical oversight for clinical and commercial manufacturing.
- External CDMO Management
- Manage and oversee relationships with CDMOs for drug substance 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
- Author and/or review 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.
Qualifications:
- Required:
- 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 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
Competencies:
- 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
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Top Skills
Aseptic Drug Product Process
Biologics
Drug Substance And Product Technology Transfer
Monoclonal Antibodies
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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