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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
Posted Today
The Director of Finance Inventory and Manufacturing Operations will lead the development and execution of processes to deliver performance based analytics for the Technical Operations organization. Key responsibilities include establishing a product costing platform to support strategic business planning, standard costing, and the annual business planning cycle. Collaborat
Posted Today
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
Posted 1 day ago
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
Posted 1 day ago
This individual will support quality control activities in the field of AAV therapeutic release and stability conducted both internally at Sarepta Andover facility and at contract vendors such as contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs). The work involves reviewing data gathered from routine testing as well as from validations an
Posted 1 day ago
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
Posted 1 day ago
Sarepta Therapeutics is seeking a motivated individual to provide laboratory support for histology and morphometrics. The contract research associate position will have the opportunity to perform a wide variety of tasks, including but not limited to operation of the automated stainer in the histology lab, maintaining lab supplies, preparation of study materials, handling a
Posted 4 days ago
Sarepta Therapeutics is seeking a motivated individual to perform scientific computing, system analysis and administrative functions to support business operations. This position engages with Sarepta's multidisciplinary researchers including study directors, pathologists, and other laboratory staff at the Ohio Genetic Therapies Center of Excellence. The Lead Analyst, Resea
Posted 6 days ago
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
Posted 6 days ago
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
Posted 6 days ago
The MSL will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta's investigational therapeutics and product pipeline. Reporting to the West Region Team Leader, the MSL position will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenn
Posted 6 days ago
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
Posted 8 days ago
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
Posted 8 days ago
This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. This individual will be responsible for assisting with the maintenance of the local archives, electronic, paper, and other records. Primary Responsibilities Include Assist with organizing, tracking, correcting, filing, and cataloging records. A
Posted 10 days ago
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
Posted 10 days ago
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