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Director of Process Development

Company: GenScript
Location: Piscataway
Posted on: June 24, 2022

Job Description:

The position reports to the Vice President of GenScript Probio, US Site Head, is ideally suited for a professional with extensive technical knowledge and a proven track record of developing processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
Key Responsibilities:

  • Participate the recruitment of process development and analytical development team, retain and develop talents, and provide leadership for a high performing team to meet overall business objectives.
  • Lead the set-up of Process Development lab. Drive the development of robust, cost-effective recombinant plasmid DNA and other novel viral vector's manufacturing processes, for client's cell and gene therapy applications. Lead the tech-transfer and process scale-up.
  • Apply Quality by Design principles to develop a deep understanding of the plasmid DNA platform manufacturing process and to define robust, integrated control strategies.
  • Establish the procedures of direct tech transfers, and the capability of process lock-in pilot runs.
  • Develop and maintain detailed and comprehensive project timelines and budgets.
  • Lead the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
  • Present updates to project or upper management teams on process development and manufacturing support activities.
  • Maintain a high level of knowledge in gene and cell therapy, sensitive in the field of plasmid DNA and other novel products development and manufacturing.
  • Perform other duties as assigned based on business needs.
  • Up to 15% traveling to support CDMO projects or business development activities.
    Qualifications:
    • Master's or Ph.D. degree in Molecular Biology, Analytical Chemistry, Immunology, Chemical Engineering or equivalent with 5+ years' experience in biotech development with particular experience in gene and cell therapy product design. Experience with recombinant plasmid DNA products a plus.
    • Technical knowledge and hands-on experience in process development of immune cell therapy technologies, gene editing and gene therapy technologies.
    • Experience in process development for scale-up manufacturing with GMP requirements, familiar with small-scale models troubleshooting approach. Familiar with growing plasmid DNA by microbial fermentation, lysis and chromatography purification process steps.
    • Experience in CMC regulatory affairs for FDA, and EMA is a plus.
    • Direct management experience with successful track record of building, coaching and mentoring a high-performing team.

Keywords: GenScript, Trenton , Director of Process Development, Executive , Piscataway, New Jersey

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