Scholar Rock · 5 months ago
Senior Director, Drug Product Development
Cambridge, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
12+ years expScholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are seeking a Senior Director of Drug Product Development to lead formulation and drug product development for biologics, ensuring successful strategy and execution across various presentations and modalities.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases—from preclinical development through commercialization
Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration, stable formulations
Oversee development and optimization of drug product processes for vials, prefilled syringes, and autoinjector device combinations
Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery
Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with device engineering, clinical, and regulatory functions
Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development
Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing
Lead technical due diligence, selection, and oversight of CDMOs for drug product manufacturing
Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality
Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes
Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies
Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and inspection support
Represent Drug Product function on cross-functional CMC and program teams
Provide leadership for global DP strategy, including oversight of internal teams and CDMO partnerships
Engage with regulatory agencies (FDA, EMA, PMDA) to support development programs and inspection readiness
Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement
Qualification
Required
Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development
Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products
Proven track record in advancing injectable drug products from early development through commercialization
Experience with PFS/AI combination products, including design control, human factors, and regulatory expectations
Strong technical leadership, project management, and cross-functional collaboration skills
Familiarity with regulatory expectations for DP development and CMC submissions in US and EU
Preferred
Experience with combination products, device development, and cold-chain distribution
Prior leadership of external CDMO partnerships
Experience with QbD-based development and global CMC strategy implementation
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
Morningstar.com
2025-12-13
2025-11-25
Company data provided by crunchbase