Senior Director, Drug Product Development
Scholar RockWant to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. Drive drug product strategy and execution across modalities and presentations—from IV to SubQ, 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 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 high-concentration (‚â•200 mg/mL), stable formulations.
- Lead development and optimization of vial and target combination product presentations (pre-filled syringe / autoinjector); collaborate to achieve patient-ready presentations; evaluate excipients, container closure compatibility, viscosity, and stability.
- Drive selection and integration of drug delivery devices (PFS/AI) with commercial, clinical, and regulatory functions.
- Establish phase-appropriate formulation control strategies and support specification setting in coordination with Analytical Development.
- Direct process development activities including fill-finish design, container closure 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 with Manufacturing and Quality.
- Apply Quality by Design (QbD) principles to develop and optimize drug product formulations and processes.
- Partner with Analytical Development to define and maintain specifications and support real-time release strategies.
- Act as technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs); respond to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA).
- Represent Drug Product on cross-functional CMC and program teams.
- Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement.
Qualifications
- Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years of biologics drug product development experience (or M.S. with 15+ years), focusing on high-concentration biologic formulations for combination products, 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 late-stage process validation.
- Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control, design verification/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.
Skills
- Drug product formulation and fill/finish process expertise
- Combination product development (PFS/AI) and device integration
- Quality by Design (QbD) and process development
- Regulatory submissions (CMC) and interaction with health authorities
- Technical leadership, program management, cross-functional collaboration
Education
- Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field (or M.S. with substantial experience)
Additional Requirements
- Experience with combination products, device development, and cold-chain distribution preferred
- Experience leading external CDMO partnerships preferred
- Experience with QbD-based development and global CMC strategy implementation preferred