Qualifications
The ideal candidate should have a proven track record in drug product development, with significant expertise in biologics, formulation, and regulatory compliance. A strong educational background in a relevant scientific discipline (PhD preferred) and extensive leadership experience in the biopharmaceutical industry are essential.
About the job
Scholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering transformative therapies for individuals facing serious diseases with significant unmet needs. As a recognized leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is committed to advancing innovative treatments that leverage protein growth factors. Over the past decade, the company has built a robust pipeline aimed at redefining the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, and cancer, where growth factor-targeted therapies can make a profound difference.
Scholar Rock stands out as the sole company to demonstrate clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). Our dedication to exploring fundamentally new therapeutic paradigms is supported by the broad application of a proprietary platform that has led to the development of novel monoclonal antibodies designed to selectively modulate protein growth factors. By applying cutting-edge scientific approaches in areas that have historically been neglected by conventional therapies, we strive to create new opportunities for patients. Discover more about Scholar Rock's innovative approach at ScholarRock.com and stay connected via @ScholarRock and on LinkedIn.
Position Overview:
We are searching for a highly skilled and experienced Senior Director of Drug Product Development to spearhead formulation and drug product development initiatives across our portfolio of biologics, which includes monoclonal antibodies, fusion proteins, and bispecifics. This pivotal role will be responsible for shaping and executing the drug product strategy across various modalities and presentations—ranging from intravenous (IV) to subcutaneous (SubQ) delivery systems, including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate will possess extensive experience in establishing strategic direction and providing hands-on leadership in formulation development, process development, technology transfer, and ensuring commercial readiness for biologic combination products. A comprehensive understanding of the technical and regulatory aspects of combination product development, encompassing drug product formulation and fill/finish processes, primary container development, and stability is essential for this position.
About Scholar Rock
Scholar Rock is at the forefront of biopharmaceutical innovation, focused on creating groundbreaking therapies that address critical healthcare challenges. Our commitment to scientific excellence and patient-centric solutions drives our mission to enhance the lives of individuals with serious health conditions.