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Director/Senior Director, Process Development

Reference Number: 3909
Location: MA

Our client is an immuno-oncology biotechnology company. They have asked us to assist them in their search for a Director/Senior Director, Process Development.

Major tasks and responsibilities will include:

  • Evaluates next generation technologies and equipment for closed system clinical scale manufacturing of autologous cellular therapy products.
  • Works collaboratively and cross-functionally with the vector process development and analytics groups to develop alternative methods for transduction of autologous T cells with retroviral or lentiviral vectors
  • Designs, generates, analyzes, and interprets experimental data from in vitro, primary human cell based assays to inform process development in the optimization of manufacturing our autologous cell based immunotherapy.
  • Troubleshoots and solves difficult problems associated with patient to patient variability.
  • Works closely with colleagues to translate R&D concepts into clinical development programs.
  • Communicates and presents scientific findings at group and company meetings.
  • Influences corporate CMC strategy and goals.
  • Collaborates with QA/QC to ensure regulatory compliance.
  • Collaborates with Legal/IP to protect scientific advancements.
  • Maintains detailed experimental records and laboratory notebook.
  • Plays a key role in partnership with relevant academic partners.
  • Assesses global regulatory authority’s guidance for cell therapy R&D and commercialization.  Play a key role in communicating with regulatory bodies.

We seek candidates with the following qualifications:

  • Master’s degree required, PhD highly preferred.
  • Must have relevant industry experience. Experience with immunology, oncology and/or immuno-oncology highly preferred.
  • Requires experience leading process development activities with cell and gene therapies, and experience advancing therapies from discovery to clinical development.
  • Demonstrated competence in mammalian cell/tissue culture techniques and flow cytometry, and in the execution of primary T-cell based assays such as activation, proliferation, cytotoxicity and cytokine release highly preferred.
  • Must have experience performing cell-based assays across multiple assay platforms, and making/using viral vectors.
  • Experience with cell therapy processing equipment such as Elutra, Cell Saver Elite, Sepax, Prodigy, CliniMACS, Wave Bioreactors, and LOVO are a plus.
  • Requires outstanding written and oral communication skills and the ability to work collaboratively.

If interested, please email your resume as a Word attachment to us, reference 3909.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.