Analytical Development Chemist I

at  AtomVie Global Radiopharma Inc

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AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

REQUIREMENTS

• University Degree in Biology, Biological Chemistry, Biotechnology, or a related discipline. M.Sc. or Ph.D is preferred.
• 3-4 years of related experience in in a pharmaceutical cGMP environment, performing analytical chemistry techniques such as HPLC, GC and TLC, microbiology tests such as Bacterial Endotoxins, and/or Biology tests such as IRF, ELISA and SDS-PAGE.
• Experience working with small molecules, antibodies, proteins and antibody-drug conjugates, protein characterization, UV/VIS, etc.
• Experience working with sterile products and working in a BSL2
• This position requires flexibility in work schedule to support a 7-day work week in support of morning to night shifts in a production environment.
• Ability to lift 23 kilograms required.

ABOUT THE ROLE

The Analytical Development Chemist I will be responsible for working in accordance with company policy and within GMPs, while contributing technical expertise to support current products and develop future drugs within the AtomVie portfolio or through support of our CDMO functions.

WHAT YOU WILL DO

• Conduct analytical method development, transfer, validation, and stability testing activities for various analytical techniques which may include Chemical, Biological and Microbiological testing methods.
• Perform testing of development drug products and stability samples using draft methods.
• Write test reports, data summaries, technical documents (e.g., specifications, release certificates), and validation protocols with input from SMEs; generate data evaluation summaries and statistical evaluations.
• Report data in client presentations; attend meetings and present data at client sessions as required.
• Conduct routine and complex validation activities as per approved protocols and methods; write validation reports in line with regulatory guidelines (ICH, USP, etc.).
• Support quality control testing of finished drug products and product development material release; coordinate quality testing of excipients, precursors, and drug substances with contract laboratories or research organizations.
• Perform quality investigations, including non-conformances and testing failures; write investigation reports (e.g., INVs, NCs, CAPAs), prepare CAPA implementation plans, and implement corrective actions.
• Participate in process improvement initiatives, including initiating change controls, revising methods, and creating new procedures (e.g., STMs, SOPs, forms, templates).
• Conduct peer reviews of laboratory records, training documents, and technical reports; train colleagues and provide feedback.
• Manage inventory of analytical reagents, critical materials, reference standards, and consumables; ensure laboratory equipment calibration, maintenance, and troubleshooting with SME guidance.
• Maintain housekeeping and hazardous waste disposal (chemical and radioactive) in compliance with AtomVie SOPs; monitor procedure effectiveness and propose improvements.
• Fulfill regulatory documentation requirements, including radioactive material transfer forms, and ensure compliance with Health Canada, FDA GMP regulations, and Canadian Nuclear Safety Commission guidelines.
• Report radiological contamination events, participate in investigations, and implement corrective actions.
• Collaborate with team members to achieve outcomes aligned with production and stability plans.
• Ensure adherence to GMP by maintaining complete records for training, analytical testing, routine operations, and equipment maintenance.
• Maintain knowledge of regulatory guidance, pharmacopeias, ICH, and applicable business protocols and procedures.
• Ensure compliance with all health, safety, and regulatory requirements for work activities.
• Plan, implement, and complete tasks in a timely manner with high quality.
• Complete all other related duties as assigned.

WHAT YOU BRING TO THE ROLE

• Experience in method development and validation, and documentation of such studies, is an asset.
• Knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is an asset.
• Knowledge of UV, IR, mass spectrometry, and NMR is an asset.
• Excellent communication skills (in English) and ability to work both independently and cooperatively in a team environment.
• Proficiency with equipment data processing software such as Empower (Waters HPLC).
• Proficiency with spreadsheets (e.g. Excel, Google Sheets), word processing software (e.g. Word) and presentation software (e.g., PowerPoint)
• Good writing skills: ability to write technical documents and reports, and the ability to rapidly input data and retrieve records, statistics, trends, etc., and to prepare technical r presentations for customer meetings.