Primary Responsibilities Include:

• Exhibit strong interpersonal and technical skills working in a team that is engaged in novel method development in AAV Gene Therapy.
• Manage the development and transfer of methods to the quality control group or external testing labs.
• Interact with AD, QC, and QA to assess the competency of the current assays and the need for continuous improvement of methods.
• Collaborate with CMC teams to develop the timelines for validation of assays and transfer to QC.
• Manage the process to set up suppliers for specialized reagents.
• Assist in stage appropriate validation of test methods for clinical products intended for early to late-stage clinical trials.
• Draft early-stage methods and convert them to SOP for easy transfer to QC.
• Author development reports, qualification protocols and qualification reports

Desired Education and Skills:

• Ph.D. degree in Virology, Molecular Biology or related field with 8 years relevant industry experience or a Master's degree in Virology, Molecular Biology or related field with 10 years relevant industry experience.
• A strong understanding of contemporary molecular biology methods with hands on experience in managing a high-performance laboratory operation.
• A demonstrable grasp of a wide range of technologies: TCID50, qPCR, ddPCR, ELISA, SDS-PAGE, in-vitro potency as applied to gene therapy products is required.
• Working in a cGMP environment engaged in release of a biologic and experience in writing regulatory documents will be additional qualification.
• Must have effective written and verbal communication skills.
• Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.

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.