Sarepta Therapeutics, Inc

In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV and RNA analytical testing and documentation for submission to regulatory agencies.. Function as an internal expert in RNA and molecular Biology test methods used for release and characterization of Gene Therapy products intended for human use.. Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections.. Extensive technical expertise with HPLC, LCMS, GC, KF, pH, Spectroscopic sequencing methods.. A strong understanding of molecular biology techniques for analysis of gene therapy products: to include (but not limited to) PCR, Infectivity, Potency, and various ELISA methods.

director quality control

The Executive Director QC leads a high-functioning QC group comprising 35-40 individuals and 3 direct reports. The ideal candidate should be highly skilled in managing external manufacturing and testing sites both in the USA and across the world. The successful candidate will foster a collaborative environment and play a key role in developing and executing the strategy for managing high throughput clinical and commercial QC testing programs to ensure a continuous, global supply of Sarepta's small molecule RNA and AAV gene therapies for neuromuscular disorders. The candidate will excel in a team-based environment, working closely with the pre-clinical, manufacturing, quality assurance and regulatory departments at Sarepta as well as acting as the liaison between external manufacturing and testing partners to ensure the accurate and timely completion of QC testing activities in support of scheduled product lot release activities. Primary Responsibilities Include: <ul><li>Managing and providing oversight of external testing sites (CTLs, CDMOs) both in the USA and across the world. </li><li>Mentor individual team members and ensure positive motivation and success of the team. </li><li>Technical lead for GMP QC data management and lot release activities.</li><li>Ensures compliance with GLP and cGMP guidelines both internally at Sarepta and at Contract testing labs.</li><li>Author IND, BLA, NDA, IMPD sections pertaining to drug product release and stability. In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV and RNA analytical testing and documentation for submission to regulatory agencies.</li><li>Engage in various regulatory discussions both internally and with regulatory agencies such as FDA, EMEA and PDMA.</li><li>Establish and manage external collaborations to accomplish key QC objectives at Sarepta.</li><li>Function as an internal expert in RNA and molecular Biology test methods used for release and characterization of Gene Therapy products intended for human use. </li><li>Oversee all Release and Stability analytical testing to ensure testing is timely and performed in compliance with cGMP, ensure product is released in a timely fashion.</li><li>Perform QC review of in process and release data and Certificate of Analysis per internal timelines, to support lot disposition.</li><li>Responsible for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs)</li><li>Establish and maintain Sarepta's specifications and sampling plans for in-process, drug substance, drug product, and stability. Manage implementation and changes in specifications at partner sites.</li><li>Collaborate on preparation of justification of specification. </li><li>Select and monitor metrics to identify risks and priorities, and improvements initiatives.</li><li>Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections.</li><li>Generate relevant QC SOPs.</li><li>Assure ongoing readiness for regulatory inspection; participate in audits and inspections, and prepare responses to correspondence and findings, as needed.</li><li>Recruit, train, and develop a team of Quality Control professionals as needed.</li></ul> Desired Education and Skills: <ul><li>MS or BS in Chemistry, Biochemistry or Molecular Biology with 15+ years of experience in pharmaceutical industry with at least 10 years of experience managing cGMP contract testing laboratories. Experience testing and releasing Advanced Therapeutic Medicinal Products (ATMPs, Gene Therapies) is highly preferred.</li><li>Extensive technical expertise with HPLC, LCMS, GC, KF, pH, Spectroscopic sequencing methods. A strong understanding of molecular biology techniques for analysis of gene therapy products: to include (but not limited to) PCR, Infectivity, Potency, and various ELISA methods.</li><li>Prior leadership experience managing high throughput QC testing groups.</li><li>Experience in planning, getting approval and managing budgets >$20 million/year. </li><li>Experience with writing procedural documents SOP, policy, validation proposals, validation reports, relevant sections of regulatory documents, IND, IMPD, NDA, BLA is useful.</li><li>Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.</li><li>Proven ability to troubleshoot operational and scientific questions, maintaining direction to a final solution.</li><li>Experience working with drug substance and/or drug product CMOs and participating in global cross functional and virtual teams.</li><li>Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs.</li><li>Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on-time and on-budget, experience with the principals of operational excellence.</li><li>Excellent written and oral communications skills</li><li>A well organized, self-motivated, and independent work style with the ability to initiate and follow-through on assignments.</li></ul> #LI-Hybrid This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $248,000 - $310,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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