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Senior Director of Injectable Product Development

Posted 8 months ago

  • Contact: Naomi Gale
  • Contact Email:
  • Contact Phone: 929-379-0799
  • Expiry Date: 02 April 2023

​SciPro has recently partnered with a globally renowned pharmaceutical company’s Injectable Drug Product formulation team on a Senior Director of Injectable Product Development. This team is currently supporting rapid pipeline development with a diverse portfolio of modalities. This team offers all the benefits of a startup's team culture while also providing strong backing as a highly-ranked large pharma company.

Position Requirements:

Advanced degree with minimum 12 years of industry experience with a focus on parenteral drug product development

  • 8-10 years of direct management experience

  • Experience leading IND/BLA submissions and responding to regulatory enquiries is required

  • Hands-on gene therapy / biologics experience

  • Experience in mid- to late-stages of drug development process (exposure to scale-up activities, PPQ planning and execution, risk analysis, etc.)

  • Experience leading a program from pre-IND to commercialization

  • Experience leading strategic initiatives for DP programs

What you’ll be doing:

  • Leading cross-functional CMC operations for the company’s injectable drug product operations

  • Supervising the late-stage development of the company’s pipeline

  • Mentoring junior colleagues for injectable development and tech transfer activities

  • Contributing extensively to IND/BLA filings and revisions

  • Working cross-functionally with DS/QC/QA/AD teams to troubleshoot product development

  • criteria and support CMC program development

  • Ensuring GMP compliance both internally and externally