Analytical Chemist – Radio Conjugate Laboratory
Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that deliver powerful alpha‑emitting payloads directly to tumors. Our pipeline spans multiple first‑in‑class programs—backed by a GMP‑compliant, brand new radiopharmaceutical facility in Hamilton, we’re turning groundbreaking science into real‑world impact for patients. Join us at the forefront of radio-pharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us!
Job Description:
The Analytical Chemist in the Radio Conjugate Laboratory leads, conducts, and supports analytical development and QC testing operations. They handle laboratory investigations, implement corrective actions, and perform technical reviews of laboratory records for radiolabeled biologics and small-molecule conjugates. This role ensures that all activities related to analytical testing including analytical method development, validation, transfer, authoring of test procedures and controlled forms are conducted as per the current Good Manufacturing Practice (cGMP) to ensure compliance with the regulatory requirements. Analytical Chemist role is encouraged to prioritize laboratory testing to meet production schedules, troubleshoot and improve test methods, independently author and complete method validations/transfers and test procedures, ensure data integrity and safety compliance (including radiological controls), and perform QC testing following authorized protocols.
The role will also prepare and lead change controls, deviations, investigations, and CAPAs, and provide training and mentorship to colleagues. This position reports to the Manager, Quality Control and requires a strong foundation in chemistry and a passion for scientific inquiry.
Key Responsibilities:
- Develop, validate, transfer, and accurately document new analytical methods with minimal supervision. Independently author validation and transfer protocols and reports in compliance with applicable regulatory guidelines (e.g., ICH, USP, EP) and internal SOPs. Diagnose and resolve instrument and method issues to ensure reliable performance.
- Create and maintain new test methods, controlled forms, and data entry templates; prepare change-control proposals and revise/improve existing methods.
- Perform release and retrospective testing of drug products and materials per approved methods, including analytical chemistry, biological, microbiological, and other compendial tests aligned with USP and EP.
- Conduct technical peer review of lab documentation and QC documents, generate Certificate of Analysis for release.
- Author specifications, test reports, data summaries, investigations, and CAPAs; develop CAPA implementation plans and support closure of laboratory investigations.
- Lead investigations into testing failures and non-conformances and implement targeted corrective and preventive actions.
- Perform all work activities in accordance with Standard Operating Procedures (SOPs)/Work Instructions (WIs); promptly advance deviations to Laboratory Management and Quality Assurance.
- Maintain, calibrate, and verify laboratory equipment to ensure accurate and reliable performance.
- Operate under Health Canada, FDA, EMEA Annex 1 and GMP requirements for sterile pharmaceuticals.
- Work in compliance with regulations set by the Canadian Nuclear Safety Commission; follow all applicable Health and Safety policies and regulations.
- Maintain laboratory housekeeping standards; handle and dispose of hazardous chemical and radioactive waste through approved waste streams.
- Provide training to colleagues within QC and cross-functional teams.
- Collaborate effectively to plan, implement, and complete assigned tasks on time while maintaining consistently high quality.
Qualifications:
- A minimum bachelor’s degree in chemistry, Biochemistry or a related field.
- Broad understanding of innovative physico-chemical analyses and ability to design and develop comprehensive analysis strategy.
- 4+ years of related experience in a pharmaceutical GxP environment, performing analytical chemistry techniques including HPLC, GC, ICPMS and TLC, microbiology procedures like Bacterial Endotoxins, and/or Biology assessments such as IRF.
- Practical understanding of Radiopharmaceutical analysis is beneficial.
- Skilled in equipment data processing tools, including Empower (HPLC, GC) and MassHunter (ICP‑MS). ICP‑MS expertise is considered an asset.
- Proficient with spreadsheets (e.g., Excel, Smartsheet), word processing software (e.g., Word), with the ability to write clear, accurate technical reports and detailed documentation.
- Strong written and verbal communication skills; ability to author/review technical documents and interact effectively during audits.
- Experience working within the framework established by the Canadian Nuclear Safety Commission (CNSC) regulatory agency is an asset for this role.
- Periods of standing working at laboratory benches, lifting up to approximately 25 lbs (e.g., solvent containers, lead shielding), and fine motor tasks
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 11 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected]
⠀
Annual base salary for this position ranges from 68,086.40 to 89,363.40.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
