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Associate Director, CMC

We are seeking a highly motivated and enthusiastic individual to join us as a CMC, Associate Director, in our R&D Therapeutics team. You will work with the research team in the exciting areas, including antibody generation and engineering, cancer immunotherapy, autoimmune disorders and other diseases. 

Responsibilities:

  • Oversees and directs all chemistry, manufacturing and controls (CMC) regulatory and manufacturing strategies for new and mature products
  • Provides guidance and support to internal groups such as marketing, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations
  • Provides strategic input and risk assessments and oversees preparation of CMC regulatory submissions
  • Interacts with regulatory agencies
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function

Requirements:

  • PhD in immunology, pharmacology, toxicology, cell biology or similar fields
  • Very strong written and verbal communication skills
  • Ability and willingness to work within a team
  • Superb organizational and leadership skills
  • Ability to take initiative
  • Ability to anticipate problems and offer solutions
  • 10-15+ years’ experience in similar role
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