• Posted on: Jul 08, 2024
  • Location: New Brunswick, NJ
  • Job ID: 83e1a6f1
  • Type: Full Time
  • Posted on: Jul 08, 2024
  • Location: New Brunswick, NJ
  • Job ID: 83e1a6f1
  • Type: Full Time

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Job Title: Head of Analytical R&D

Job Summary: We are seeking a dynamic and experienced Head of Analytical R&D to lead our Method Development and Validation team in support of Pharmaceutical Drug Product Development. This role is critical in overseeing analytical efforts from preclinical through IND/NDA, 505(b)(2) and ANDA submissions, primarily focusing on small molecule drug development, with an emphasis on strong leadership and project management skills.

Key Responsibilities:

  • Lead and manage the Analytical R&D team, ensuring successful method development and validation.
  • Provide analytical support for new drug development, from preclinical through IND/NDA submissions.
  • Oversee analytical aspects of drug product development, ensuring compliance with regulatory standards.
  • Collaborate with cross-functional teams to support overall drug development projects.
  • Manage timelines, resources, and budgets for analytical projects.
  • Maintain up-to-date knowledge of regulatory requirements and industry trends.
  • Support biologics development as needed, although the primary focus is on small molecules.

Qualifications:

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  • Extensive experience in analytical R&D, with a strong background in method development and validation.
  • Proven track record of providing analytical support for IND/NDA submissions.
  • Experience in new drug development from preclinical to regulatory submission stages.
  • Strong leadership and project management skills.
  • Excellent communication and interpersonal abilities.
  • Proficiency in instrumental techniques such as HPLC, GC, MS, NMR, and FTIR.

 

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