Senior Specialist, GMP QA

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:

The Senior Specialist will support the Quality Assurance (QA) department in the planning, execution and management of outsourced (Contract Manufacturing Organization – CMOs). The individual will assist in lot disposition as well as managing other GMP activities. The specialist will have responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in areas of GMP compliance. Strong organizational skills are required, as well as the ability to balance changing priorities.   

• Review and approval of Master Batch Records Contract Manufacturing Organizations (CMO)
• Review of executed batch records from Contract Manufacturing Organizations (CMO)
• Perform lot disposition
• QA support to contract manufacturing operations (attend meetings, approval of CMO documentation)
• Track/maintain metric logs related to lot release 
• Assist with SOP writing and revisions and other QA activities as required
• Assist in investigation and deviation activities, and CAPAs, and provide general quality assurance support for the overall Quality System at Scholar Rock.
• Assist with change controls including Change Control Review Board and manage change control records
• Manage the External Notification Quality System 
• Assist with temperature excursions during shipment and storage of GMP materials
• Provides QA guidance and recommendations in a professional and collaborative manner to internal and external stakeholders

• Bachelor’s Degree preferred
• 3-5 years of experience with general Quality Systems in a regulated environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing
• Proven ability to work independently and effectively handle multiple priorities 
• Ability to maintain confidentiality of proprietary information expected.
• A good team player that takes initiative to complete tasks diligently and correctly.
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization.
• Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.