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 (TGFß) 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 an enthusiastic and highly motivated Manager/Senior Manager, Quality Control. The role of Manager/Sr. Manager, Quality Control will be integral to the growing QC function at Scholar Rock as the programs progress from the R&D to cGMP stage, readying for commercialization and beyond. The successful candidate will be responsible for: helping to define, communicate and implement the company's quality control strategy and vision as part of the QC team. This role will utilize strong relationships to collaborate and interact with our development, clinical and operations teams to accomplish the company's objectives. This individual will also collaborate and develop strong relationships with external CTL's/CMO to ensure the appropriate testing, systems, processes, and activities are in place for Scholar Rock's products. The successful candidate will utilize strong communication and relationship building skills to oversee Quality Control functions through external services.
A successful candidate will possess experience in analytical CMC, and potentially including interactions with the FDA and other agencies. Experience interacting with and managing external resources (CTO's/CMO's) is required. Ability to exert influence diplomatically and have a positive impact inside and outside of the organization. Demonstrated interpersonal, organizational, negotiation and communication skills. Excellent oral and written communication skills and computer skills. Ability to travel as needed.
\n Position ResponsibilitiesReview CTL/CMO's tests raw data and make sure that tests are done in accordance with approved SOPs and results interpretation is correctManage and analyze the stability programs of the GMP DS, the GMP DP and the development (shelf extension) DS/DP and write periodic Technical Reports. Rapidly informs and updates appropriate teams of OOT and OOS data.Work with collaboration partners to ensure project deliverables Oversee CTL/CMO analysis documents, validations, and batch records Provide analytical support and input to developmental studies and issues during product development to ensure quality upon QC transfer/transition to commercial-readinessAuthor/review department SOPs Candidate RequirementsBachelor's Degree in appropriate scientific field with 8+ years of experience, or equivalent combination of experience and advanced degreeKnowledge of regulatory guidelines (GxP, FDA, ICH, EU, etc.). Focus on biologics is a plus. Excellent writing and communication skillsExperience overseeing QC laboratory functions performed by a third-party CDMO or CTLStrong technical analytical background
\nScholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.