Senior Manager, GMP
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: August 29, 2021
Company
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, and fibrosis. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By exploiting structural differences in the precursor, or latent forms of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
Our first investigational product candidate, apitegromab (SRK-015), is a selective inhibitor of the activation of latent myostatin. We announced positive 12-month top-line data from the TOPAZ trial in April 2021, demonstrating that apitegromab has the potential to improve motor function in patients with Type 2 and Type 3 spinal muscular atrophy (SMA). We anticipate initiating a Phase 3 registrational trial by the end of 2021 and are moving steadfast towards our aim of bringing this potential first muscle-directed therapy to patients with SMA
Our second investigational product candidate, SRK-181, is a selective inhibitor of latent TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapies (CPIs), such as anti-PD-1 or anti-PD-L1 antibodies. Although CPIs have transformed the cancer treatment landscape, only approximately 20% of patients respond to treatment. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from CPIs. We are evaluating SRK-181 in the ongoing DRAGON Phase 1 proof-of-concept trial (NCT04291079) evaluating patients with locally advanced or metastatic solid tumors. We anticipate initial clinical response and safety data from Part A (dose escalation) portion of the trial by the end of 2021.
We continue to progress our scientific platform and preclinical programs as we apply our structural insights and protein science and antibody expertise to discover antibodies with differentiated therapeutic profiles and develop high-impact medicines for patients suffering from serious diseases.
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.
Position Responsibilities:
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- 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.
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Quality Management System:
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- 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.
Candidate Requirements:
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- 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.