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Process Development Manager
2 months ago
Job Summary
A dynamic oncology biotech company in Vancouver, BC is seeking a driven Associate Director of Process Development to lead the CMC process development for innovative radiopharmaceutical clinical programs.
Required Qualifications:
- 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.
Responsibilities include:
- 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.
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