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Director of Gene Therapy Analytical Development

Location
New York City, NY, United States

Posted on
Aug 14,2019

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My client is expanding and looking to hire a Director of Gene Therapy Analytical Development.nnThe ideal candidate will take on the following tasks:nn* Provide subject matter expertise and leadership in developing analytical methods for AAV product release testing and product characterizationnn* Oversee CROs and CMOs for developing, qualifying, and validating analytical assays for AAV productsnn* Act as a CMC lead in analytical development team, lead the design and execution of comparability and stability studies for multiple programsnn* Oversee development, validation and execution of methods that are suitable for the release and stability of AAV based gene therapy productsnn* Technical lead for GMP method development, validation, method transfer, data analysis and reporting -- ensure compliance with GCP, GLP and cGMPnn* Author and review assay development and validation reports, relevant sections of documents pertaining to AAV analytical methods development and documentation for submission to regulatory agencies.nnThe ideal candidate will possess the following qualities:nn* PhD in Analytical Chemistry, Biochemistry, or similar with 5 years industry experiencenn* Experience with viral vectors is requirednn* Previous management of CROs and CMOs is preferrednn* Experience setting specifications based upon statistical analysisnn* Thorough knowledge of GMPs, ICH, USP, EPnn* Review of deviations, OOS, OOT, and change controlsnn* Experience authoring CMC regulatory filings including IND, CTD and IMPDnn* In-practice knowledge of the ICH for assay qualification and validationnn* Strong, demonstrated ability to thrive in a fast-paced biopharmaceutical environmentnn* Prior experience in developing and validating methods in a GMP/GLP environmentnn* Experience with writing validation protocols, validation reports, relevant sections of regulatory documents, IND, IMPD and BLAnn* Experience in directing the development and validation of molecular biology test methods not limited to PCR (qPCR, ddPCR), Viral Infectivity, ELISA, SDS Page, Capillary Electrophoresis, AUC, and cell based potency assays at external sitesnn* Excellent technical writing and communication skillsnnThis is a field based role and the ideal candidate is based on the East Coast -- Boston, New York, Philadelphia, Baltimore, Washington DC, etc.,

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My client is expanding and looking to hire a Director of Gene Therapy Analytical Development. The ideal candidate will take on the following tasks: Provide subject matter expertise and leadership in developing analytical methods f...
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