Position Responsibilities:
- 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.
Candidate Requirements
- 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.
- 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
What We Do
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.
For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/
For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
