Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are planning to advance to a Phase 3 trial by year-end. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative, fun and experienced team. Our mission is to help patients with serious illnesses by applying innovative thinking, cutting edge monoclonal antibody and protein science, and our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the Sr. Manager GMP Quality Assurance will be relied upon as Subject Matter Expert in GMP Compliance in the manufacture and disposition of Biological Investigational Product for use in Clinical Studies. The Sr. Manager GMP Quality Assurance coordinates GMP Compliance activities with Technical Operations, CMC Regulatory Affairs and Quality Control in support of manufacturing MCB/WCB, Bulk Drug Substance, Vialed Drug Product manufactured, tested, labelled and kitted externally at CMOs.
This role will have high level of involvement in continuous improvement of GMP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally. We are looking for someone that understands “phase appropriateness” and is capable of shepherding the Quality of Manufactured products as they develop in their lifecycle and compliance requirements. This individual will help build out QMS at Scholar Rock and work with key stakeholders to achieve continuous inspection preparedness.
Oversight of GMP Manufacturing:
Manage the Scholar Rock Lot disposition process including: Review of GMP Manufacturing Documents including Batch Records, Investigations, Deviations/CAPA, Analytical Testing Documents and Certificates of Analysis
Managing the review of these documents by third party consultants when necessary
Managing timelines and resources to ensure disposition of material in accordance with Scholar Rock SOPs and within project timelines
Manage Internal and Vendor investigations to successful completion and to Scholar Rock standards including Root Cause Assessments and assessment of impacts on Product Quality
Represent QA in Material Review Board meetings
Coordinate with the Vendor Audit Lead to ensure GMP vendor audits are scoped appropriately, participate in audit planning meetings, review of Audit Reports and audit responses to ensure compliance.
Coordinate with the Director GMP QA, Technical Operations and other internal parties to ensure successful Process Validation and PPQ runs for pre-commercial product.
Quality Management System:
Review and modify existing Scholar Rock GMP/QMS SOPs to streamline processes with an eye for greater compliance, reduced risk and efficiencies.
Coordinate with Director of GMP QA and Functional Area Leads to develop new SOPs at Scholar Rock to support GMP activities and build out required components of QMS.
Manage the Change Control process for GMP activities internal to Scholar Rock including coordination with internal parties as well as external vendors for closure of Change Actions. Ensure Change Controls are executed and closed in accordance with Scholar Rock SOPs.
BS in a scientific discipline with 8 years biotech/pharmaceutical industry experience
5 Years’ experience in pharmaceutical/biopharmaceutical cGMP Quality Assurance and strong working knowledge of cGMPs requirements for manufacture of Investigation Product
Extensive experience with review of batch record, analytical testing, deviations/investigations, lot disposition and Change Controls
Strong experience with leading and managing quality investigations and representing QA on Material Review Boards
Experience in managing CMOs deviations, investigations, CAPA and driving process improvements
Strong auditing experience as well as experience managing audits performed by third party auditors
Strong leadership and negotiation skills
Must have excellent verbal, written and interpersonal communication skills
Capable of working in a matrixed and dynamic work environment
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.