Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
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
- 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
- Represent QA in Material Review Board meetings
- Coordinating with Clinical Operations and Quality Control/Stability to determine product impact on Investigation Product that experiences temperature deviations
GMP Vendor Audits and Oversight:
- Manage the Scholar Rock GMP Vendor Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both Auditors and Vendors
- Coordinate with Project Team members to insure vendor audits are appropriately scoped and that third party auditors are provided all they need to prepare for the audits
- Processing submitted Vendor Audit Requests and ensuring the audits are scheduled according to stakeholder timelines
- Review contract auditor draft audit reports, ensuring they meet Scholar Rock QA standards and are compliant with Scholar Rock SOPs. Managing the review/editing cycle until reports are acceptable for approval
- Submitting Observation reports to vendors, communicating response timelines and tracking them to ensure timely responses
- Review of vendor audit responses and Managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy. Updating CAPA trackers
Quality Management System:
- Review and modify existing Scholar Rock GMP/QMS SOPs to streamline processes with an eye for greater compliance and reduced risk
- Manage the processing of SOPs through the Document Change Control system including the review/editing cycle (Pleasereview), routing DCR Forms for signatures, scanning and archiving of originals, ensuring training on new SOPs/revisions are completed and that documents are transitioned from “Approved” to “Effective” status.
- Periodic review of training files to ensure training/training documentation is current.
- 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 and lot disposition
- 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.