Radiopharmaceuticals Development Lead

5 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time
Lead Radiopharmaceutical Development Specialist

We are seeking an experienced Lead Radiopharmaceutical Development Specialist to join our team at AtomVie Global Radiopharma Inc.

About the Role:

As a key member of our Analytical Development team, you will be responsible for planning, implementing and successfully completing assigned analytical development projects (e.g., method development, transfer, validation activities, and related tasks) while ensuring consistent high quality and compliance with cGMP.

Key Responsibilities:

  • Lead development projects, prepare presentations, attend client meetings, and provide expert technical advice to clients.
  • Plan, implement and successfully complete assigned Analytical Development (AD) projects while ensuring consistent high quality and compliance with cGMP.
  • Responsible for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.).
  • Write test reports, data summaries, and statistical evaluations/trending.
  • Conduct review of Analytical Development laboratory records / notebooks.
  • Assist in the management of third-party analytical testing service providers.
  • Conduct all work in accordance with AtomVie SOPs and raise any deviations immediately to the attention of Management.
  • Perform quality control "testing of incoming materials, drug substances and finished drug products according to standard testing methods.
  • Perform peer/technical review of QC data.
  • Perform routine quality operations including technical document review, calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.
  • Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety.

Requirements:

To be successful in this role, you will need:

  • A D. in Chemistry, Chemical Biology, Biotechnology or a related discipline.
  • ~10 + years' hands-on experience in a pharmaceutical GMP environment, specifically in laboratory sample preparation techniques, operation of HPLC, GC, and TLC, and method transfer, development and validation.
  • ~ Knowledge and experience in UV, IR, mass spectrometry and NMR, microbiological release testing of pharmaceuticals (e.g. Bioburden, Sterility, and Bacterial Endotoxins) and testing of biologicals are assets.

What We Offer:

  • Group Health & Dental Benefits (from day 1)
  • A competitive salary of $120,000 - $180,000 per year, depending on experience
  • The opportunity to work with a leading global radiopharmaceutical company
  • A dynamic and supportive work environment
  • The chance to contribute to the development of innovative radiopharmaceuticals that improve patient lives

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