Radiopharmaceutical Development Scientist

4 days ago

Hamilton, Ontario, Canada AtomVie Global Radiopharma Inc. Full time

Are you a chemistry expert looking for a challenging role in the pharmaceutical industry?

AtomVie Global Radiopharma Inc. is a leading manufacturer and distributor of clinical and commercial radiopharmaceuticals, and we are seeking an experienced Analytical Scientist to join our team.

We offer a competitive salary of $120,000 per year, as well as a range of benefits including group health and dental insurance, an RRSP matching program, and Perkopolis perks.

About the Role

The successful candidate will have a Master's or Ph.D. degree in Chemistry, Chemical Biology, Biotechnology, or a related discipline, and at least 10 years of experience working in a pharmaceutical GMP environment.

  • Main Responsibilities:
  • Lead development projects, prepare presentations, and provide expert technical advice to clients.
  • Plan, implement, and complete assigned analytical development projects while ensuring consistent high quality and compliance with cGMP.
  • Provide analytical support for process development, including characterization of starting materials, intermediates, API, and finished products.
  • 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.
  • Perform troubleshooting and investigations in cross-functional teams under the direction of management.
  • 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.
  • Write, revise, and review INVs, NCs, CAPAs.
  • 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.
  • Troubleshoot equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.).
  • Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety.
  • Ahere to Health Canada, GMP/GDP regulations, and maintain compliance with Health, Safety, and Environment protection rules.
  • Complete all other related duties as required.

We are committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients.

What You Bring to the Role
  • Working knowledge of GLP/GMP and applicable FDA, EMA, ICH, and EANM guidance documents.
  • Good verbal and written communication skills, strong numeracy skills, and the ability to work both independently and as part of the team.
  • Demonstrated ability to successfully organize, prioritize, manage time, multitask, and troubleshoot.
  • Proficiency with spreadsheets and Ms. Office and ability to write technical documents and reports.
  • Flexibility in work schedule to support a 24/7 production environment based on customer demand, including weekends.
  • Ability to work in a facility that handles radioisotopes and radiopharmaceuticals.
  • Capable of standing, walking, and/or sitting for extended periods of time. Ability to lift 23 kilograms required.

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