Scientist, Validation Engineer, Pharmaceutical Science/ Research
Listed on 2026-07-26
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Pharmaceutical
Validation Engineer, Pharmaceutical Science/ Research, Pharmaceutical Manufacturing, Regulatory Compliance Specialist
Job Details
Job Title: Scientist
Location: Hamilton, Ontario
Work Type: Onsite 5 days/week
OverviewFusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radio conjugates 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—turning groundbreaking science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us!
RoleThis role will support the design of manufacturing and analytical processes as well as the technology transfer, in‑house and with CDMO partners. The position reports to the Associate Director of Process Development and Technology Transfer. It requires collaborative skills, multi‑tasking ability, and the desire to thrive in a fast‑paced environment. The successful candidate will bring a strong background in radio labelling, radio metal chemistry and analytical method development, and have knowledge of manufacturing within the biotech or pharmaceutical industry.
Responsibilities- Build and complete lab work related to the development of manufacturing and analytical processes for targeted alpha therapies and related compounds.
- Analyze generated data and report outcomes to the project’s teams.
- Lead or support the technology transfer of newly designed manufacturing and analytical processes.
- Generate supporting documentation for newly designed processes such as development reports, SOPs, work instructions, and validation documentation.
- Participate in validation and qualification activities for new clinical manufacturing processes and analytical methods, as necessary.
- Support the CMC group during investigations (non‑conformance, deviation, out‑of‑specification).
- Minimum MS with 5+ years of experience in product development and manufacturing; advanced degree in organic or analytical chemistry, radiochemistry, radiopharmaceutical sciences, pharmaceutical science, chemical engineering, or related discipline.
- Experience in radiopharmaceutical manufacturing and analytical method development and validation.
- Experience with manufacturing process design using an automated synthesis unit is an asset.
- Knowledge of radiation safety principles/dangerous goods and regulations (e.g., CNSC, NRC).
- Strong interpersonal skills; leadership in cross‑functional manufacturing projects.
- Excellent written and verbal communication skills.
- Meticulous, self‑motivated, decisive, and independent with a willingness to work in a fast‑paced environment.
- Available to travel to various locations (primarily in North America).
Annual base salary ranges from $82,377.60 to $. Permanent positions offer a variable pay bonus, equity‑based long‑term incentive program (if applicable), competitive flex benefits and retirement savings program, 4 weeks of paid vacation, and annual personal days. Fixed‑term contract/temporary positions receive a contract benefits program.
Equal Opportunity EmployerAstraZeneca is an equal opportunity employer committed to diversity and inclusion and providing a workplace free from discrimination. Accommodation is available on request for persons with disabilities. Apply by emailing AZCH
This advertisement relates to a current vacancy.
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