The Senior Manager of Technical Operations will help drive the development of Sarepta's Gene Therapy and RNA Therapeutics platforms. Working within the broader Technical Operations department, he/she will be responsible for managing key business operations projects with particular focus on strategic commercial/clinical supply agreements and process development contract neg

The Associate Director, Commercial Diagnostics & Bioinformatics reports into the Executive Director, Commercial Diagnostics and plays a key role in driving the strategic vision and objectives to make Sarepta a recognized leader in precision genetic medicine for rare diseases. The Associate Director, Commercial Diagnostics analyzes genetic diagnostic data to provide insight

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 position will be responsible and accountable for leading the Global Program Team (GPT) to create and execute an integrated development strategy which coherently integrates the clinical, non clinical, regulatory, medical affairs, manufacturing, commercial, and market access plans to support successful submissions, approvals, launch, and life cycle activities. It will c

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

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

The Data Scientist, Research Sciences role at Sarepta is an exciting opportunity for someone with strong data science and analytical skills who wants to see their work directly impacting patient care. In this hands on role, the data scientist will research and develop advanced analytical methods to utilize internal and external chemistry and biological data to support all

Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead Primary Responsibilities Include Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM,

Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and c

Co lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of su

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 Senior Manager, Capital Projects operates within the Real Estate, Facilities and Engineering department. This position develops facility projects (lab, office and Current Good Manufacturing Practice (cGMP) Manufacturing), both renovation and new construction, to support the Sarepta Capital Improvement Program, from initiation stage through planning, design and construc

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

The person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more Gene therapy programs. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact to the development of transformative therapies that

The Senior Manager, Supply Planning & Analytics will support various clinical and commercial programs and will be responsible for ensuring uninterrupted drug supply across the entire global drug supply manufacturing network. The candidate will work closely with Global Supply Chain, Manufacturing, Clinical Ops, Commercial, Quality, and third party vendors to ensure end to e