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

This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. The candidate will have a clear understanding of the data capture process and will perform QC review of gene therapy research data under direct supervision. The candidate will assist with tracking, trending, and reporting results. The candidate

Developing Technician / Electrician Executes tasks as directed, limited scope for independent tasking and judgement. Electrical focus. Moderate supervision with limited independent judgement required. Can problem solve while working and learning under guidance. Executes repetitive work independently and more complex work as part of a team. Works on problems of limited scop

Sarepta Therapeutics is seeking a motivated individual with necropsy and histology related experience. The Lead Research Associate will provide critical laboratory management for all research teams through preclinical animal tissue and sample collection work at the Ohio Genetic Therapies Center of Excellence. The candidate will lead the necropsy function, coordinating necr

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 Finished Goods Lead of Quality Assurance Operations would perform the person in plant oversight for Sarepta quality operations (for clinical and commercial) related to Gene Therapy CMOs. This person will oversee on site batch record review with on the floor support at the Philadelphia facility and perform product disposition activities. They would provide oversight of

The Director, Competitive Intelligence will manage the Customer organization's competitive intelligence function. This includes maintaining timelines, industry knowledge, market alerts, conference coverage, primary market research, and Leadership briefings on competitive events as they occur. This position partners with several functions throughout the organization to ensu

The Sr. Manager reports to and serves as a strategic partner to the Executive Director, Head of Global Field Medical Strategy & Launch Execution ("Executive Director"). The supported function includes Sarepta's HCP focused field medical teams (US and global) and medical launch execution. The position works closely with the Executive Director to establish the function's str

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

Job Description Summary Entry Level Technician Executes simple tasks as directed, very limited scope for independent tasking and judgement. Works on problems of limited scope, under established guidelines or supervision. Follows standard practices and procedures in maintaining building equipment. Able to document activities as required by regulation or SOP. Performs genera

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

Sarepta Therapeutics is seeking a motivated Scientist with laboratory experience in developing and executing molecular assays and leadership expertise to manage the development of predictive biomarkers for late state clinical trials. The qualified candidate will have strong, hands on background with molecular assays and able to execute routine assays according to the estab