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Analytical Scientist

2 months ago

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

AtomVie Global Radiopharma Inc. is a leading manufacturer and distributor of clinical and commercial radiopharmaceuticals. We collaborate with partners to advance high-quality drugs for disease treatment and diagnosis.

Job Summary

We are seeking an Analytical Scientist to join our team. As an expert in analytical test method development, transfer, and validation, you will provide technical leadership and project management support across Analytical Development, Production, and QA teams.

Key Responsibilities
  • Lead development projects, prepare presentations, 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.
  • Provide analytical support for process development, including characterization of starting materials, intermediates, API, and finished products.
  • Responsible for new equipment purchases and installation, including 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.
Requirements
  • M.Sc. or Ph.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)
  • RRSP Matching Program
  • Perkopolis
  • Employee Assistance and Wellness Programs
  • Parking Allowance

AtomVie is 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. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.