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Associate Director, Process & Analytical Development - Viral Vector

  • Location: United States of America
  • Job Type:Permanent

Posted 25 days ago

  • Contact: Brian Zinco
  • Contact Email: b.zinco@Sciproglobal.com
  • Contact Phone: 6469898936
  • Expiry Date: 09 October 2022

​SciPro has been retained on an Associate Director of Viral Vector Process Development & Analytical Development/Gene Delivery with a Top 5 global pharma company. The Company is looking for a highly experienced and motivated Process Sciences leader to contribute to the development of their industry leading Cell & Gene Therapy pipeline, build out a brand new team from scratch, manage and lead a team direct reports, and be responsible for Viral Vector Process & Analytical Development strategy.

The major responsibilities include:

  • Lead global strategy for Viral Vector Process & Analytical Development initiatives supporting both viral/non-viral delivery

  • Build a brand new team + lab from scratch to support Process & Analytical Development

  • Lead Analytical Tech Transfers globally for Manufacturing success, lead Process Characterization campaigns, and spearhead PD/AD initiatives from pre-clinical to pivotal phase

  • Represent Viral Vector CMC team in technical and program reviews with key internal/external stakeholders

  • Define key milestones for the Viral Vector CMC team and manage all activities to ensure execution of the development plans

  • Support regulatory submissions such as IND & BLA filings

Qualifications

  • BS, MS, with 15+ years of pharmaceutical industry experience or PhD and over 8 years within CGT or biologics product development

  • 2+ years of direct management experience (preferred to have experience building teams from scratch)

  • Candidate coming from a large molecule background, Gene Therapy/virus experience is preferred

  • Highly collaborative with a proven track record of building cross functional teams

  • Experienced CMC when it comes to defining strategy and execution of key programs

  • Exceptional interpersonal skills, communication, negotiation skills, and ability to present key data to stakeholders

  • Extensive IND/BLA experience