Director of Analytical Development (Gene Therapy) – Top $$

Job Type: 
Clinical Research and Development
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, an RTP biotech that is doing cutting-edge research in the field on gene therapy, is actively recruiting for an exceedingly competent and knowledgeable leader to direct all Analytical Development functions.  This is a critical and impactful role within the organization and company will pay industry-leading wage to retain and attract a star.

Key Things to Note:

  • This company and its leaders have been on the forefront of the gene therapy industry. They seek leaders who are similarly innovative, visionary and resourceful.
  • This Director oversees Analytical from Phase I through Commercial.  Understanding the nuances and best practices for analytical testing throughout the product life cycle will be essential.
  • This Director will supervise a team of ~ 4 (and growing).  We seek a developmental manager of people.
  • The company heavily relies on CMOs and third-party testing labs.  Seek candidate accustomed to directing the work of outsourced vendors.
  • This is an emerging company in building mode.  Right candidate will be a hands-on leader who will successfully develop strategies, tactics, policies and procedures for a growing and changing organization.

Position will involve leading the planning, development, qualification and execution of analytical assays to support internal Research & Development, Process Development and recombinant Adeno-associated virus (rAAV) vector manufacturing.

Specifics:

  • 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

Selected candidate will offer a M.S. or Ph.D. degree in Bioanalytical Chemistry, Biology, Biochemistry, Virology or related field as well as 7+ years of directly related experience in Analytical Development. Knowledge of FDA and EMA cGMP standards for analytical development assumed and required.   Specialization in Gene Therapy and familiarity with rAAV vectors is strong preferred. Other priorities include:

Familiarity/expertise in the following:

  • PCR, sequencing, qPCR, SDSPAGE, HPLC, ddPCR, cell-based assays, ELISA, SEC, etc.
  • Cell characterization technologies including GRO_Seq, DNA_Seq, qPCR, Western blot, ELISA, etc.
  • Aseptic skills, vector engineering, high-throughput gene expression technology and cell line engineering
  • Cell and molecular biology techniques including cloning (eg.Gibson and Golden Gate Assembly) and gene editing technologies such as CRISPR/Cas9
  • Mammalian cell line engineering using gene editing/KD approaches (CRISPR, Meganuclease and si/shRNA).

In addition, we seek a candidate who brings:

  • Substantial skill in experimental design, execution, data analysis, statistical analysis and troubleshooting
  • Sound understanding of statistical experimental design and analysis such as design of experiments
  • Outstanding team leadership and supervisory/management skill
  • Longevity and impact in previous roles

Finally and critically, we seek a candidate who will thrive in this dynamic, empowered, collaborative and mission-driven setting -- a hands-on, unspoiled scientist who is capable of handling the complex, ambiguous scientific challenges, while respecting and handling the more mundane, but still important, basic tasks. Unwavering commitment to excellence, team and patient will be critical.

This is an immediate need and a Direct Hire opportunity.  Please forward Word resume for prompt reply.  Local candidates targeted at this time.