Director, Analytical Development

Director, Analytical Development

Director, Analytical Development

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Accentuate Staffing is exclusively working with one of our Pharma companies in the RTP area.  We are currently recruiting a Director of Analytical Development to lead the overall set up their Analytical Department and take this start-up to the next level!

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.

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 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

Requirements:

  • M.S. or Ph.D. degree in Bioanalytical Chemistry,  Chemistry, Biology, Biochemistry, Virology or related field with at least 7-10 years relevant experience
  • Working knowledge of qPCR, ELISA, SDS-PAGE/Western blot, HPLC, RP-HPLC, HPLC-SEC and cell based potency assays etc

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