Associate Director, Gene Therapy Quality Control Operations

Sarepta Therapeutics

16h•Onsite

About The Position

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role Reporting to the Sr. Director of QC Operations, the Associate Director of QC operations is responsible for supporting the operations of the internal ddPCR, qPCR and Cell-based assays. The individual will be responsible for supporting all aspects of the laboratory and facility footprint including safety, compliance, instrumentation and equipment qualification and maintenance. Prior experience with laboratory expansion projects is beneficial. This role is responsible for inventory management, raw material procurement as well as the qualification and bridging of critical reagents needed to support internal and external testing at our CMO/CTL partners. The Associate Director of QC Ops is responsible for the supervision of laboratory ops personnel and the optimization of department resource allocation according to project/program needs to assure activities occur in an efficient, safe, timely and cGMP compliant manner. The Opportunity to Make a Difference Manage the inventory for all reference standards, assay controls and critical reagents qualification, bridging, and expiration extension Generate Certificate of Analysis for critical reagents in compliance with cGMP Monitoring KPIs associated with laboratory performance, productivity, run time and efficiency Establish cross-functional relationships with Sarepta CMC stakeholders to aligned goals, timelines, and resource requirements Establish and manage external collaborations to accomplish key Sarepta objectives Proactively identify opportunities to improve operational efficiency, communication, and program outcomes Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories Procure new equipment and support timelines for qualification Support quality events associated with Laboratory investigations, deviations, change controls, etc. Author regulatory submission sections and address questions from health authorities regarding critical reagents Manage spend through budget planning, Scope of Work requests, invoice reconciliation, and change orders More about You MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience required Direct working experience in AAV products is highly desired. Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting. Experience operating liquid handlers is beneficial. Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives. Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats. Laboratory expansion experience is beneficial Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment. What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Onsite #LI-ES1 This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $160,800 - $201,000 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Requirements

MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience required
Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting.
Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.

Nice To Haves

Direct working experience in AAV products is highly desired.
Experience operating liquid handlers is beneficial.
Laboratory expansion experience is beneficial

Responsibilities

Manage the inventory for all reference standards, assay controls and critical reagents qualification, bridging, and expiration extension
Generate Certificate of Analysis for critical reagents in compliance with cGMP
Monitoring KPIs associated with laboratory performance, productivity, run time and efficiency
Establish cross-functional relationships with Sarepta CMC stakeholders to aligned goals, timelines, and resource requirements
Establish and manage external collaborations to accomplish key Sarepta objectives
Proactively identify opportunities to improve operational efficiency, communication, and program outcomes
Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories
Procure new equipment and support timelines for qualification
Support quality events associated with Laboratory investigations, deviations, change controls, etc.
Author regulatory submission sections and address questions from health authorities regarding critical reagents
Manage spend through budget planning, Scope of Work requests, invoice reconciliation, and change orders