Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. Summary of Position:
Scholar Rock is seeking a highly experienced and technically strong 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. This role will be responsible for driving drug product strategy and execution across modalities and presentations—from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.
Position 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.
Candidate Requirements:
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:
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.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
