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 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

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

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

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 is seeking an experienced psychometrician to join our Patient Centered Outcomes Research Team. As a psychometrician in this role, you will be instrumental in designing, developing, and validating patient reported outcomes measures and assessment tools to evaluate the impact of our portfolio of products on patients' outcomes. Your work will directly contribute to ou

Works as Global Regulatory Leads (GRLs). Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Represents Regulatory at the Global Development Team with relevant line function leaders. Develops and delivers on fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to supp

We are seeking a hands on team player who enjoys collaborating with colleagues and shares a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. The candidate in this role will be supporting method transfer from the analytical development group and the establishment of cell based assays in the process analytics laboratory. T

The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub team structure and serving as a member of the GRT. The Senior Manager will a

The Manager, Medical Reviewer provides operational oversight of medical materials review within the Medical Affairs function reporting to the Director of Global Medical Review. This individual works closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, Medical Affairs and Clinical Development to assure that all

The Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Qu

Sarepta Therapeutics is looking for an energetic and resourceful HR Informations Systems Technical Analyst. As an HRIS IT Technical Analyst, you will play a crucial role in supporting and optimizing our Human Resource Information System (HRIS), with a specific focus on Workday. Your expertise will be essential in ensuring smooth system operations, data integrity, and effec

The Scientist I, Bioinformatics works closely with several groups within Sarepta's Research and Development department. The Scientist I, Bioinformatics is part of the Genomics and Data Sciences team and plays a critical role in supporting Discovery Biology to advance our portfolio of RNA, gene therapy, and CRISPR based gene editing therapies to treat neuromuscular and CNS