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Director of Process Development

Reference Number: 2941
Location: MA

Our client is a leading biotechnology company.  They have asked us to assist them in their search for a Director of Process Development.

The Director of Process Development oversees and directs the development, scale-up and implementation of new gene therapy-related processes, analytical methods, process instrumentation and equipment to achieve cost effectiveness and that meet quality, cGMP, and regulatory standards.  Goals include the definition of scalable, compliant (feasible), state-of-the-art, & efficient production processes (upstream & downstream) in support of therapy products portfolio.

Major tasks and responsibilities will include:

  • Oversees and/or direct the generation of cell and viral banks necessary to support process development and clinical manufacturing.
  • Acts as a liaison with all essential internal functional groups and external collaborators, consultants, CMOs, and/or specialists.
  • Provides technical and prudent strategic direction related process development and cGMP implementation.
  • Keeps current on trends, new products and technologies, and regulatory requirements that may have an impact on the corporation’s development and manufacturing plans.  Serves as a subject matter expert (SME) related to viral and gene therapy-related technologies, strategies, CMOs, and regulatory considerations.
  • Develops, explores and/or applies new approaches to technology development or process development in the gene therapy space.
  • Works with senior management to ensure goals area aligned with strategic direction of corporation.
  • Manages the Gene Therapy Development staff of technical professionals to achieve project and organizational objectives via individualized goal-setting, oversight, feedback, technical direction, and coaching.
  • Effectively manages Gene Therapy Development resources (e.g. budget, capital, headcount, allocations, etc.) and provides senior management with input related to such.
  • This position reports to the VP of Early Process Development.

We seek candidates with the following qualifications:

  • A Ph.D. in biology, virology, molecular biology or a related area and 10+ years of relevant experience or an MS and 15+ years of relevant experience or a BS and 18+ years of relevant experience.
  • A strong background and proven experience in the areas of viral based gene therapy expression platforms.
  • Experience and a working knowledge of gene therapy biologics development, CMC, and regulatory submission requirements, processes and considerations.
  • Experience with gene therapy related cell culture, purification and analytical strategies, equipment, and processes.
  • Strong written and oral communication skills, and the ability present and defend positions and approaches critical to program progression and success.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2941. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.