Associate Director of Process Development

1 week ago


Vancouver, British Columbia, Canada GQR Full time

Job Summary:

A dynamic oncology biotech company is seeking a driven Associate Director of Process Development to lead the CMC process development for innovative radiopharmaceutical clinical programs.

Key Responsibilities:

  • Execute the CMC development strategy and IND-enabling activities to support the clinical manufacturing of Drug Products (DP).
  • Collaborate with a multidisciplinary team to guide the process development of radiopharmaceuticals for Phase 1 clinical trials.
  • Oversee the process development of Drug Products from drug candidate selection through to IND submission.
  • Facilitate the establishment and ongoing management of the radiochemistry laboratory to support both pre-clinical and clinical translational development.
  • Serve as the primary CMC representative, liaising with research radiochemistry and in vivo teams to share best practices and ensure effective knowledge transfer.

Requirements:

  • MSc or PhD in a relevant scientific field with at least 6 years of experience in the pharmaceutical industry, specifically with biologics and/or antibodies.
  • Experience with radiopharmaceuticals is highly desirable.


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