Senior Director, Drug Product Development

Role Summary

Senior Director of Drug Product Development to lead formulation and drug product development efforts across Scholar Rock's portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. Responsible for driving drug product strategy and execution across modalities and presentations—from intravenous to subcutaneous, including high-concentration formulations, prefilled syringes, and autoinjectors. Requires extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. Deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, and stability.

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 target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a patient-ready combination product presentation. 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 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 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.

Qualifications

• Required: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ 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. Alternatively, M.S. with 15+ years of experience.
• Required: Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products.
• Required: Proven track record in advancing injectable drug products from early development through commercialization including success in managing late-stage process validation studies.
• Required: 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.
• Required: Strong technical leadership, project management, and cross-functional collaboration skills.
• Required: 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.
• Preferred: Prior leadership of external CDMO partnerships.
• Preferred: Experience with QbD-based development and global CMC strategy implementation.