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AtomVie Global Radiopharma

Analytical Development Chemist

Hamilton, ON, Canada

Pay: Up to $74,000 CAD / year
Job type: Full-time
Posting language: English
Posted: Sep 16, 2026

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Original job description

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.

About the Role

The Analytical Development Chemist 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.

This posting is for an existing vacancy to support the expansion of the company.

Location: AtomVie Global Radiopharma Inc, Hamilton ON (Onsite).

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.

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.

Compensation: Annual salary starts at $74k.

AtomVie Offers

Group Health & Dental Benefits (from day 1)
RRSP Matching Program
Perkopolis
Employee Assistance and Wellness Programs
Parking Allowance

AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.

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. 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.

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More about this job

Responsibilities

The Analytical Development Chemist will conduct analytical method development, validation, and stability testing while ensuring compliance with GMP and regulatory standards. They will also manage quality investigations, write technical reports, and support the release of drug products and materials.

Requirements

Candidates must hold a university degree in Biology, Biotechnology, or a related field, with a Master's or PhD preferred. A minimum of 3-4 years of experience in a pharmaceutical cGMP environment performing analytical chemistry and microbiology techniques is required.

Skills

Analytical method development
GMP compliance
HPLC
GC
TLC
Microbiological testing
Empower software
Technical writing
Validation protocols
Quality investigations
CAPA
Protein characterization
ELISA
SDS-PAGE
Data analysis

Benefits

Group Health & Dental Benefits
RRSP Matching Program
Perkopolis
Employee Assistance and Wellness Programs
Parking Allowance

Visa sponsorship

Not detected in the job text

Keywords

Analytical Development
Radiopharmaceuticals
GMP
CDMO
Method Validation
Stability Testing
HPLC
GC
TLC
Microbiology
Bioburden
Sterility
Bacterial Endotoxins
Empower
CAPA
Non-conformance
ICH
USP
FDA
Health Canada
CNSC
BSL2
Protein Characterization
ELISA
SDS-PAGE
Small Molecules
Antibody-drug conjugates
Quality Control
Regulatory Compliance
Technical Documentation

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