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Director, Drug Substance Development and Manufacturing

Company: Job Juncture
Location: New Brunswick
Posted on: January 17, 2020

Job Description:

My client seeks a Director to lead efforts from early development through commercialization and life cycle management for several drug modalities. The ideal candidate will take on the following tasks:


  • Leads drug substance development, technology transfer support, and process characterization activities
  • Oversee external CMOs for drug substance process development and manufacturing activities and tech transfer to GMP manufacturing facilities
  • Supports GMP manufacturing including PIP, data monitoring and data analysis, troubleshooting manufacturing issues, and deviation closeout as appropriate
  • Provides solid understanding of applicable global regulations and industry standards and supports regulatory filing, review the dossier, prepare NDA
  • Collaborate with drug product development, analytical development, discovery and research, QA, supply chain, regulatory, legal and IT

    The ideal candidate will possess the following qualities:


    • MS/PhD and 10+ years of drug substance process development
    • Experience in early and late stage development programs, including commercial stage products
    • Ability to travel 25%
    • Tele-commuting option -- can be based in NYC, Boston, Philadelphia or Washington DC areas

Keywords: Job Juncture, New Brunswick , Director, Drug Substance Development and Manufacturing, Executive , New Brunswick, New Jersey

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