Director – Analytical Development

We are seeking a Director, Analytical Development, to provide the planning, development, qualification and execution of analytical assays to support internal R&D, process development and recombinant adeno-associated virus (rAAV) vector manufacturing. This individual will lead an analytical team whose goal will be to provide bioanalytical test method development, qualification and validation support. The team will develop analytical methods to be used for in-process, release and stability testing of rAAV gene therapy.

Responsibilities and Accountabilities

  • 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 rAAV 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
  • Evaluate CRO/CMO test results and write summary reports of the results when needed
  • Develop strategies to transfer these methods when needed to our partners or collaborators
  • Represent Analytical team in meetings and provide leadership to analytical scientists

About you: 

  • MS or PhD degree in bioanalytical chemistry, biology, biochemistry, virology or related field with at least 7-10 years of relevant experience
  • Demonstrated experience in analytical techniques such as PCR, sequencing, qPCR, SDS-PAGE, HPLC, ddPCR, cell-based assays, ELISA, SEC, etc.
  • Experience with mammalian cell culture techniques
  • Self-motivated, organized, capable of working independently, as well as in a collaborative/group environment
  • Strong oral and written communication skills
  • Good judgment and innovation to achieve a solution within standard practices and procedures
  • Strong analytical and computer skills are required
  • Sound understanding of statistical experimental design and analysis, such as design of experiments, is a plus
  • Knowledge of Microsoft Office suite (Word, Outlook, Excel) required; experience with JMP a plus
  • Experience with global teams, especially Spanish speaking, a plus
  • Ability to successfully participate in a highly-creative, enthusiastic start-up environment