Sarepta Therapeutics Job Trends

The Associate Director of Market Access and Reimbursement (ADMAR) is responsible for serving as the primary field-based contact for education, assistance and issue resolution for healthcare providers (HCPs) and sites of care with respect to patient access and reimbursement for Sarepta’s products. The territories this role will support consist of Washington, Oregon, Idaho, Nevada and Montana. This role requires fundamental level of knowledge in the market access and reimbursement journey encompassing procurement, payer policies and coverage, benefit design, prior authorizations, appeals, exceptions, denials, coding and payer payment guidelines, site of care regulation/requirements, understanding of coding guidelines (CPT/J-Code/ICD-10), commercial and/or statutory...

The Senior Director charged with overseeing all internal Quality Control Testing will lead a group of high-functioning QC analysts comprising approximately 50 individuals organized under 3-5 direct reports. The ideal candidate will be highly skilled in managing an integrated testing schedule that supports both a high-throughput late-phase, commercial manufacturing supply chain as well as a dynamic early phase clinical pipeline. The successful candidate will foster a collaborative environment and play a key role in executing the strategy that ensures a continuous global supply of Sarepta’s AAV gene therapies for neuromuscular disorders. The candidate will excel in a team-based environment, working...

This role will serve as a leader for the Research Operations Clinical Trial Support function and is responsible for planning, implementation, execution, and oversight of specialty clinical lab testing (conducted internally and externally) in partnership with subject matter experts from Translational Biology, Immunology, and Genomics. The individual will also oversee and/or provide input on vendor selection and contracting, sample management and reconciliation, clinical site training, and site feasibility. The position will work cross-functionally with Clinical Operations, Project Management, Compliance, Data Management and other teams supporting clinical trial execution. The Opportunity to Make a Difference Provide comprehensive oversight of specialty lab...

The QC Associate II, Potency will work as a member of the Quality Control-Internal Testing team and will be responsible for testing gene therapy products using cell-based and ELISA based test methods. All testing will be done in compliance with current Good Manufacturing Processes (cGMP) and will support clinical and commercial lot release and stability activities. Available positions are all facility-dependent and require a full-time on-site presence (hybrid or remote hours are not available). All positions will be based in the Sarepta Quality Control Laboratories located in Andover, MA. The successful candidate will have hands-on experience with either cell-based in-vitro...

The Senior Manager, Real World Evidence (RWE) Operations will play a pivotal role in supporting both operational and research activities within the RWE and Prospective Research teams working with Global Health Research Analytics (GHRA) team. This individual will be responsible for driving forward the execution of Phase IV and Registry studies, collaborating with internal and external stakeholders, and ensuring efficient coordination of project timelines, budgets, and deliverables. This position requires a proactive individual with strong organizational skills, strategic thinking, and attention to detail. The Opportunity to Make a Difference Project management of internal and external research initiatives Manage day-to-day activities...

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 necropsy with vivarium teams and study directors as needed. The candidate will lead and assist in the coordination of effort across teams and facilitate efficient high quality sample collection and processing. This role requires laboratory expertise/training in small and large animal handling and specialized necropsy techniques. The qualified candidate will...

Sarepta Therapeutics is seeking a motivated facility-dependent scientist with expertise in ligand-binding and PCR-based assay development, validation, execution, and reporting with a specific emphasis in non-clinical GLP studies and outcomes. The qualified candidate will provide scientific oversight into the development strategies and validation studies in alignment with current regulatory guidance for Bioanalytical Method Validation. This position will lead day-to-day GCP/GLP analysis on non-clinical and clinical samples, ensuring the requirements of approved protocols, methods, and procedures are upheld. This position will prepare relevant sections of testing study/contributing scientist reports and regulatory documents. The position includes integration of data across platforms, study...

Career Level Technician – Executes tasks autonomously, works with wide latitude for independent judgement and prioritization with minimal supervision. The Opportunity to Make a Difference Under minimal supervision executes routine and non-routine tasks that are within functional area of responsibility Mentors and guides more junior technicians. Learns from others and can independently learn, troubleshoot basic and moderately advanced systems. Completes work requests, preventative maintenance tasks within CMMS and can write own preventative maintenance schedules or work requests. Works cross functionally with other departments and empowered to understand scope of decisions within their control. Manages outside vendors and their work within...

The engineer will make critical contributions towards the development and lifecycle management of Sarepta’s Gene Therapy platform within the downstream process development team. They will be primarily responsible for contributing to the development, characterization, optimization, scale-up and transfer of the downstream processes to generate purified viral vectors for therapeutic use. This individual will be performing lab-based downstream process development activities. The engineer will be expected to work effectively with other downstream engineers, as well as colleagues in the process analytics, upstream, pilot and manufacturing organizations. The Opportunity to Make a Difference Independently perform clarification, filtration (Normal & Tangential), and chromatography...

The Associate Case Manager supports physicians, patients and families as a member of the International Patient Services Team. Paired with a Case Manger(s), the Associate Case Manager supports the team through data updates to patient records, tracking case status, set-up of new patient referrals and patient/physician outreach. The Associate Case Manger will learn and master all skills of Case Management. The Opportunity to Make a Difference The Associate Case Manager supports physicians, patients and families as a member of the International Patient Services Team. Paired with a Case Manger(s), the Associate Case Manager supports the team through data updates to...

The Associate Director, R&CD QA Pharmacovigilance, with minimal supervision, will support the management of GVP quality oversight, GVP-related audit program and for providing regulatory/GVP guidance. This position will liaise with internal groups such as Pharmacovigilance Operations, Safety Evaluation & Risk Management, and Market Research, as well as external groups including contract auditors in an effort to ensure a high level of quality and consistency across the Sarepta platform; design and oversee the audit strategy; assist the GVP team in identifying and implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable...

The Safety Scientist will join the Global Pharmacovigilance (GPV) department and support risk management, safety reporting and quality management activities under the direct guidance of a Safety Physician. The Safety Scientist will represent GPV in cross-functional teams and meetings, to monitor and evaluate safety information while minimizing the risk of assigned products. The Opportunity to Make a Difference Support risk management activities by requesting, gathering, consolidating, performing preliminary analysis, and preparing safety data for integration into risk management plans, product labeling, investigational brochures, and Development/Company Core Safety Information. Support routine signal detection, signal analysis, and maintenance of signal management tracker...

This position is crucial for leading the Global Program Team (GPT). The Global Program Team Lead (GPTL) drives and executes a comprehensive strategy that integrates clinical, non-clinical, regulatory, medical affairs, manufacturing, commercial, and market access plans. The goal is to ensure successful submissions, approvals, launches, and life cycle activities for assigned programs. The role also fosters a culture of collegiality and respect, promoting high-performing teams and embedding the Patients First culture in all decision-making processes. The Opportunity to Make a Difference Ensure team accountability for functional deliverables, challenging assumptions, and plans. Collaborate with GPT members, cross-functional leaders, and stakeholders to...

The role of bioinformatics software engineer at Sarepta is an exciting opportunity for someone with a background in science and software engineering. In this hands-on role the bioinformatics software engineer will support Genomics and Data Science projects, as well as collaborations across Research and Development. As a member of a bioinformatics software engineering and data architecture sub-team, you will make cloud-based tools and applications that leverage Sarepta’s data fabric and the team’s genomics expertise to pull the genetic therapies of tomorrow into today. As you build your portfolio, you will have opportunities to participate in projects that run across the...

The Senior Manager reports to the Associate Director, Director, or Senior Director of Research and Clinical Development QA Nonclinical, or directly to the head of Research & Clinical Development QA in the absence of an immediate supervisor in R&CD QA Nonclinical Quality. The Senior Manager will be responsible for providing general QA Compliance and Quality System oversight to Sarepta, Columbus, OH site in support of nonclinical and clinical sample testing studies and validation of bioanalytical and biomarker assays. This position will liaise with Gene Therapy Center of Excellence (GTCOE) and Translational Biology personnel, as well as external groups including contract...

The Process Engineer co-op reporting into the Manufacturing Sciences & Technology (MS&T) team will gain an overview of MS&T responsibilities including general knowledge of cGMP manufacturing, process control strategy, and tech transfer of gene therapy pharmaceutical products to contract manufacturing. This role provides the opportunity to play a key role in spearheading projects, to gain exposure to a wide variety of Gene Therapy manufacturing activities and manufacturing process statistical data analysis. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams outside of MS&T as part of this co-op experience....

Reporting to the Director, Research & Clinical Development Quality Assurance, the Senior Manager, Research & Clinical Development QA, Audit Management will be responsible for monitoring and evaluating the compliance of clinical studies and Sarepta’s oversight of studies to FDA and International regulations and guidelines, as well as corporate policies and standard operating procedures. The Senior Manager will participate in vendor risk assessment and vendor qualification, GxP audit consultation management, and the development of performance, quality and risk metrics. Investigator site and internal process audit coordination and execution are additional aspects of this role. This position will also participate in inspection...

The Strategic Operations team shapes strategies, processes, and operations to provide ongoing solutions for core business issues faced by the Customer Organization. The AD/Director of Continuous Improvement will lead innovation and partnerships in project management, business operations, and marketing operations, with the goal of optimizing processes, enhancing productivity, and ensuring the highest standards of quality and efficiency. This role focuses on identifying the sources of business issues, defining critical success factors, developing structured approaches to deliver solutions, and building critical relationships within the Customer Organization. The Opportunity to Make a Difference Develop and Implement Strategies Identify and develop strategies for...

This individual will work with a team engaged in providing technical services on cell-based assays (Potency assay, Infectious titer TCID50 assay). The individual will support the optimization of cell and molecular biology assays being conducted in Andover, MA and conduct laboratory support processes such as maintaining cell cultures. The candidate must have hands-on experience in cell culture techniques, in vitro Potency, Western blot (automated preferred), protein extraction, and protein quantification methods. Experience with qPCR, and/or ddPCR are also desired skills. The work involves performing assays in a QC-GMP BSL-2 environment and the individual will work alongside other team members to...

The GxP Document Control co-op at Sarepta offers you the chance to lead a project to create and revise all controlled document templates, including policies, standard operating procedures, specifications, test methods, etc. The co-op will use their design skills in Word to enhance formatting and improve user experience to streamline document creation. The co-op will manage controlling (uploading, routing, and approvals) for all templates within Sarepta’s electronic Quality Management System (eQMS) and support various day-to-day Document Control Operations. This role will help you learn good documentation practices, understand global regulatory requirements, and sharpen your communication skills by interacting with professionals...

The Packaging Engineer co-op will learn overview of parenteral pharmaceutical business & industry. The emphasis will be learning and understanding of drug product distribution systems and maintaining product integrity to deliver products to pharmacies, clinics, and hospitals to dispense. This co-op will be supporting major project work as well as researching and recommending testing protocols as needed. Additionally, the co-op will support department functions including packaging system qualification, testing, reporting and artwork development. This experience is a great opportunity to gain holistic knowledge of the Supply Chain roles and responsibilities. The Opportunity to Make a Difference This application is for...

The Quality Assurance Operations co-op provides students with an overview of Gene Therapy Manufacturing - Quality Assurance responsibilities including general knowledge of Quality Review Process of GMP Production Batch Records and Change Controls. The co-op will receive hands-on experience in developing the skills to lead and drive Continuous Improvement initiatives aimed at Error Reduction and Quality Review optimization. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams to support the timely release of high-quality products to serve patients globally. The Opportunity to Make a Difference This application is for...

The Global Regulatory Affairs Chemistry, Manufacturing and Control (GRA-CMC) co-opportunity provides students with an overview of Regulatory Affairs (RA) responsibilities including general knowledge of global health authority requirements and guidance to develop regulatory CMC strategies to enable the development and/or lifecycle management of pharmaceutical products. The co-op will receive hands-on experience in developing the skills to prepare various global regulatory CMC submission documents for products in drug development and lifecycle (commercial) space, all while being an active contributor to the GRA-CMC Team. In addition, the co-op will have a unique networking opportunity to manage their own project by working in...

The Associate Director, Commercial Insights & Analytics is responsible for ensuring actionable recommendations and solutions that support the commercial success and launch of Sarepta’s current platform and other pipeline products. This position partners with Brand teams to ensure effective and impactful leverage of market research, competitive intelligence, and analytics initiatives. As a member of the Commercial Operations department, the AD also partners with Competitive Intelligence, Data Science, Analytics, Operations, and Forecasting to coordinate business insights generation and communication. The Opportunity to Make a Difference Shape the strategy of the businesses by developing a robust, cross-functional insights generation program. Develop, execute...

The Clinical Trial Co-op will report into the Clinical Operations Program Lead (COPL), Immunoassay, Clinical Program Strategy and is responsible for the assessment, development, and improvement of clinical operational processes and supportive tools. As a co-op, you will gain valuable hands-on experience working alongside the Clinical Operations Program Lead on real-world projects, including process improvement initiatives, while learning about our clinical trial operating model. The Opportunity to Make a Difference This application is for a 6-month co-op program that will start on July 7th, 2025 , and conclude on December 19th, 2025 . This is a full-time, 40 hours a...

The Information Technology (IT) department is seeking an IT co-op who will be responsible for front line support for hardware (laptops, printers, iPhone, iPad), software (installations, troubleshooting), permissions (Active Directory, Entra AD, Okta), and other services as they arise. The co-op will also be a contributing member on projects as directed by management. This is a great hands-on opportunity for students who are looking for experience in systems administration in the biotech industry! The Opportunity to Make a Difference This application is for a 6-month co-op program that will start on July 7th, 2025 , and conclude on December 19th,...

Sarepta Therapeutics is seeking a motivated individual to assist in the upstream process development to advance Sarepta’s Gene Therapy platform to treat rare diseases. The co-op will support the development and optimization of robust, well-characterized, high-quality and high-yielding cell culture processes for viral vector production. Additionally, the co-op will contribute to the understanding and development of emerging upstream technologies for future viral vector production. This role offers the opportunity to gain valuable knowledge of process workflows and stay at the forefront of the current viral vector production industry. The Opportunity to Make a Difference This application is for a 6-month...

Global Procurement & Strategic Sourcing (GPSS) collaboratively builds strategic sourcing solutions for Sarepta’s businesses around the globe to create value from our supply base, ensure the highest quality products and services are supplied to our patients, and support the Company’s growth. The co-op will gain valuable insight into the procurement function of a fast-paced biotech company and an understanding of the pivotal role procurement plays in maximizing value across the organization. The co-op will receive learning experiences and meaningful work that challenge and reward, working on projects that align with the needs within the procurement function. The dynamic nature of...

The co-op in gene therapy downstream process development will give insight into the manufacturing process for complex viral vectors along with hands-on production experience using bioprocessing techniques – including depth filtration, tangential flow filtration, and liquid chromatography. The co-op student will not only have the opportunity to interact with the downstream team, but also the upstream, analytical development, and formulation teams to learn how drug products are developed safely, cost-effectively, and efficiently from lab scale (≤10L) to commercial scale (>1000L). In addition, co-op students will be exposed to leading-edge development approaches and technologies used to overcome major challenges in the...

This is an exciting opportunity for a highly motivated and creative individual to work in a key drug discovery group in our research organization, and play a central role in applying and managing immunology and assay development studies. The successful candidate will work in the lab conducting immuno-assays to support the advancement of Gene Therapy. The candidate will closely with cross-functional teams, such as research scientific leads, research and lab operations, and program management. The individual will be responsible for creation of project plans, identifying and tracking critical path/activities, risks, contingencies, and alternatives and communicating routinely with cross-functional teams. The...

The QC Potency Team at Sarepta Therapeutics is seeking a motivated and detail-oriented co-op student to join our team. This position offers a unique opportunity to gain hands-on experience in a cutting-edge biotechnology environment, working alongside experts in the field of gene therapy. This individual will support quality control testing conducted at the Sarepta Andover facility. As a co-op, you will directly contribute to the quality control processes that are essential for the release and stability of clinical and commercial products. Your work will help ensure that our therapies meet the highest standards, ultimately impacting the lives of patients with...

We are seeking a motivated and detail-oriented Quality Assurance (QA) Co-Op to join our dynamic team in the Quality Management department. This internship provides an excellent opportunity to gain experience in the biotechnology industry and clinical research via a Quality lens. The Co-Op will gain hands-on experience in clinical quality assurance practices, learn about quality management systems that support clinical trials, and assist with managing Health Authority (e.g., FDA) inspections which lead to drug approvals, and help maintain a culture of quality excellence. The Opportunity to Make a Difference This application is for a 6-month co-op program that will start...

The Associate Engineer will drive the development of Sarepta’s Gene Therapy platform within the Pilot team. They will be primarily responsible for assisting the Pilot team in downstream operations, providing support in the installation and operation of downstream production equipment. The Associate Engineer will support scale-up studies and material production campaigns within Sarepta’s internal laboratories. They will also provide production support of cell culture and solution preparation operations and complete associated process documentation. The Associate Engineer will be expected to work in close collaboration with other Pilot Team members, as well as colleagues in development and manufacturing organizations. The Opportunity...

The Engineering Co-op student will work alongside Senior Project Managers on multiple projects during the planning, designing, and construction phases. While at Sarepta, we will give you a panoramic view of how project management and engineering work, how decisions are made, how design drawings are built and progress, how construction gets done, and how important your professional networks, connections, and collaborations will be in defining your long-term career experience. We aim to give you the skills, insight, and career guidance to be an essential part of your professional development. The Opportunity to Make a Difference This application is for a...

The Global Medical Affairs Senior Specialist plays an important role in executing operational tasks and supporting the Medical Strategy GMA Leads (GMALs) within the GMA function. This position will assist with a wide range of responsibilities to enhance the capacity of the team to focus on critical priorities and align communications, resources, and processes. This position also includes coordinator duties to support the overall operations of the team. This role is meant for a highly motivated and proactive individual who thrives in a cross-functional environment and in synthesizing insights to promote optimal team functioning. Communication and collaboration are critical, along...

The Director, RNAi Global Medical Affairs Lead (GMAL) builds alignment on key initiatives including optimal approach to data generation, communication and support of Sarepta’s RNAi pipeline therapies. The RNAi GMAL represents Medical Affairs on key cross functional teams and interfaces with internal and external stakeholders to enhance the scientific and clinical understanding of RNA interference therapies. This role is accountable for Global Medical Affairs strategic and tactical planning and serves as a key driver towards execution of these plans. The Opportunity to Make a Difference Lead the development and hold accountability for the execution of relevant RNAi therapies GMA strategy...