This individual will support routine testing conducted at Sarepta Andover laboratory charged with the execution of Nucleic Acids Testing (release and stability) related to Sarepta' s Gene Therapy pipeline conducted internally. The individual will conduct GMP QC release and stability testing using state of art Quantitative Polymerase Chain Reaction, qPCR, Droplet Digital PC

This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. The individual will devise, troubleshoot, and validate cell based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. This role would facilitate activities

The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline. The Associate Director will build and oversee a team of eight to ten QC technicians with responsibilities that include but are not limited to

This individual will join the Analytical Development team involved in the development of novel AAV Gene Therapy analytical methods. The individual will have an in depth knowledge of AAV gene therapy analytical methods that include qPCR, ddPCR, TCID50, rcAAV, SDS PAGE, CE, ELISA, AUC, FACS and potency (in vivo and in vitro). The Associate Director should have demonstrable s

Career Level Technician Executes tasks autonomously, works with wide latitude for independent judgement and prioritization with minimal supervision. Minimal supervision with wide latitude for independent judgement. Intermediate problem solving responsibilities with guidance and assistance as needed to learn. Executes work independently or as part of a team. Trains lower le

The QA Senior Associate is responsible for batch record review and disposition of clinical and commercial lots. The Senior Associate will be a key member of QA team in the assessment of CMO batch compliance with FDA and ICH regulations as well as internal procedures. This person will also be responsible for deviation and investigation review and closure and data entry. In

This individual will support analytical development activities conducted at Sarepta Andover facility in the field of in vitro potency of AAV based Drug products. The individual will help in the development and validation of cell based in vitro potency assays. The position requires a strong background in cell culture, sample preparation and protein analysis. The work involv

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 fo

The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies. Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem

The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pipeline. The Data Manager will be responsible for oversight and review of release and stability d

The Sr. Manager, GxP Training position is responsible to manage Sarepta's global GxP Training Program. The position will reside on site in the Andover, MA facility, reporting to the Director of Global Quality Systems. The position encompasses a variety of training management responsibilities, including maintaining a compliant GxP Training Program in accordance with US and