Scholar Rock · 1 day ago
Senior Director, Drug Product Development
Cambridge, MA
Full-time
Hybrid
Director/Executive
$240K/yr - $330K/yr
12+ years expScholar Rock is a biopharmaceutical company focused on developing innovative therapies for serious diseases. They are seeking a highly experienced Senior Director of Drug Product Development to lead formulation and drug product development efforts for biologics, including monoclonal antibodies and fusion proteins, overseeing strategy and execution from preclinical development through commercialization.
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 (≥200 mg/mL), stable formulations
Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. 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 commercial, 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 and technical support 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 engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support
Represent Drug Product function on cross-functional CMC and program teams
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 with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors
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 including demonstrated success in managing late-stage process validation studies
Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, 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
Business Wire
2026-01-12
Morningstar.com
2025-12-13
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