The Director of QCTS is responsible for overseeing the operations of the internal molecular and cell-based assay teams. The individual will support method validation and transfer activities conducted at Sarepta in compliance with cGMP regulations. Additionally, this role will provide oversight of method development and validation activities conducted at the contract test laboratories (CTL). The Director of QCTS is responsible for the supervision of QCTS personnel, and the optimization of department resource allocation according to project/program needs to assure activities occur in an efficient, timely and cGMP compliant manner. Primary responsibilities include: Manage the QCTS teams that develop, validate and transfer molecular and cell based assays. 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 Monitor multiple gene therapy programs to ensure the QCTS deliverables are met. Proactively identify opportunities to improve team efficiency, communication, and program outcomes. Support method validation and transfer activities conducted at Sarepta and at the contract testing/manufacturing facilities in compliance with cGMP regulations. Support critical reagents qualification, bridging and expiration extension. 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. Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories. Support quality events associated with OOS/OOT investigations, deviations, change controls, etc. Author regulatory submission sections and address questions from health authorities. Manage activities associated with budgeting, SOW, invoice, and change orders. Desired Education and Skills: MS/BS in Molecular Biology, Biochemistry, Chemistry with 10 years relevant industry experience; MS or BS with 15 years of industry experience in Pharma / Biotech industry required Experience working with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting Demonstrable experience in developing and validating molecular and cell-based methods in a GMP/GLP environment. 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 #LI-Onsite This position requires work on site at one of Sarepta’s facilities in the United States. 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 leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.