Scholar Rock · 2 months ago
Senior Director, CMC Process Development
Cambridge, MA
Full-time
Onsite
Director/Executive
$240K/yr - $330K/yr
12+ years expScholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are seeking a Senior Director of CMC Process Development to lead biologics process development, ensuring robust and scalable processes for clinical and commercial success.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
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
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
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
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
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
Qualification
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 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
Company
Scholar Rock
Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.
51-200 employees
H1B Sponsorship
Scholar Rock has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$743MKey Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M
Leadership Team
Jay Backstrom
Chief Executive Officer
Recent News
Business Wire
2026-01-12
Morningstar.com
2025-12-13
Company data provided by crunchbase