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Director - Analytical Development

Research Triangle, NC, USA | Asklepios Biopharmaceutical

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
  • Experience:
    7-10 years
Job Description:
75 people have viewed this job

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

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