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Director, Analytical Development (Science & Biotech)
Durham, NC 27703
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Jun 08, 2019
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Job Description

The purpose of the Director of Analytical Development is to provide the planning, development, qualification and execution of analytical assays to support internal Research & Development, Process Development and recombinant vector manufacturing. The successful candidate will have a Master’s or PhD degree in Bioanalytical Chemistry, Chemistry, Biology, Biochemistry, Virology or related field and have a working knowledge of qPCR, ELISA, SDS-PAGE/Western blot, HPLC, RP-HPLC, HPLC-SEC and cell based potency assays etc. This individual will lead an analytical team whose goal will be to provide bioanalytical test method development, qualification and validation support. The successful candidate will lead a team that is developing analytical methods to be used for in-process, release and stability testing of gene therapy products.
Major Responsibilities:
• Drive analytical testing support for R&D and Process Development teams to assist in the development and analytical characterization of new capsids, therapeutic cassettes and improved manufacturing process steps.
• Develop and optimize bioanalytical test methods for gene therapy products intended for non-clinical and clinical applications
• Work closely with our partners for qualification and validation of analytical methods
• Author development reports, study protocols, SOPs and pre-validation reports
• Evaluating CRO/CMO test results and writing summary reports of the results when needed
• Develop strategies to transfer these methods when needed to our partners or collaborators
• M.S. or Ph.D. degree in Bioanalytical Chemistry, Chemistry, Biology, Biochemistry, Virology or related field with at least 7-10 years relevant experience