Scholar Rock is a biopharmaceutical company seeking an experienced Senior Director of CMC Process Development to lead biologics process development across early-stage, late-stage, and commercial programs.
Requirements
- 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
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Four Day Work Week
- Tuition Reimbursement
- Relocation Assistance