ASSOCIATE DIRECTOR, ANALYTICAL DEVELOPMENT

The individual will manage the Cell Line development to advance Sarepta Therapeutics pipelines from research through clinical development towards commercialization. The individual will lead generation and characterization of novel, disease-relevant immortalized cell lines that are suitable for the drug potency and the MOA method development. The individual will also be responsible and serve as SME for tech transfer activities to Contract Development and Manufacturing Organizations (CDMO) for manufacturing of cell banks. The individual will also be required to manage 2-6 staff members who would assist in this endeavor.Primary Responsibilities include:• Lead cross-functional program teams (for multiple drug candidates), including representatives from clinical, nonclinical, regulatory, and CMC, to execute on the drug development strategy.• Work closely with all team members to forge a path that avoids gridlock and manage activities and risk to achieve cost-efficient but rapid delivery times.• Facilitate team meetings to drive cross-functional communication, decision making, and successful execution of programs and accountability to commitments and timelines.• Apply Project Management best practices, from development of agenda to distribution of meeting summaries, to follow up of all relevant action items.• Develop in-vitro potency methods for AAV based gene therapy products intended for clinical and commercial applications using a strong knowledge of AAV virology and host cell line manipulation.• Improve existing immortalized cell lines or generate novel cell lines that are susceptible to transduction with rAAV and are suitable for drug potency MOA method development.• Develop strategies for stage-appropriate validation and transfer of these methods to Internal and External Quality Control laboratories and manage lifecycle of these methods.• Function as the Sarepta liaison with CTLs to coordinate method transfer and on-site validations in the US and overseas.• Maintain clear and concise lab records and documentation.• Author development reports, study protocols, and pre-validation reports.• Assist QC with review of test methods, proposals, protocols and reports as needed.• Train and mentor junior staff members.Education and Skills Requirements:• Ph.D. degree in Bioanalytical Chemistry, Biology, Biochemistry, Virology or related field with at least 5+ years of relevant experience.• Experience in managing a team of 2-6 Associates in a laboratory setting.• A strong understanding of drug potency method development and validation as applied to gene therapy products.• Extensive experience with cell line engineering and immortalization, rAAV assays, ELISA, Fluorescence, qPCR and ddPCR, SDS PAGE, Western Blot and other quantitative analytical methods.• Working in a cGMP environment and experience in writing regulatory documents desired• Effective written and verbal communication skills is a must.• Operate as part of a team; assist fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.• Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.#LI-OnsiteThis position requires work on site at one of Sarepta’s facilities in the United States.The targeted salary range for this position is $156,000 - $195,000 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.SummaryLocation: Andover, MAType: Full time