Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radioconjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet the demand for our growing pipeline of RCs.
Overview
The Microbiology Supervisor is responsible for leading and supervising all aspects of microbiological control in a regulated aseptic manufacturing environment, with a focus on sterile radiopharmaceutical products. This role combines technical microbiology expertise with hands-on supervisory responsibilities, ensuring robust contamination control, high-quality environmental monitoring, radiological controls and compliance with global regulatory standards (including EU Annex 1 and GMP). Other duties can be assigned as required.
Responsibilities
- Microbiology Leadership: Lead and mentor the microbiology team, supervising daily lab operations and resource planning to meet manufacturing and clinical/commercial supply timelines; manage workload and performance, and drive continuous training to maintain meticulous quality and compliance standards.
- Aseptic Process & Risk Assessment: Oversee aseptic process design and simulation, risk assessments, evaluate changes, ensuring compliance with regulatory requirements.
- Environmental Monitoring: Establish, maintain, and analyze environmental monitoring programs and EMPQ, perform trend analysis and conduct contamination risk assessments.
- Contamination Control: Maintain the site’s Contamination Control Strategy (CCS), including cleanroom zoning, gowning, and disinfectant programs.
- Cleanroom Oversight: Monitor cleanroom operations, working cross-functionally with production teams to ensure GMP compliance, best aseptic practices, and effective microbiological controls.
- Regulatory Compliance: Act as SME for EU GMP (incl. Annex 1), FDA cGMPs (21 CFR 210/211, Part 11), PIC/S, ICH Q8–Q10/Q9(R1), ISO 14644/13408, relevant sterilization standards (ISO 11135/11137/17665), and compendial requirements (USP/Ph. Eur./JP), ensuring microbiology operations, EM, methods, data integrity, and validations meet internal and external expectations across all markets.
- Incident Investigation: Lead contamination event investigations, root cause analysis, CAPA implementation, and process improvements.
- Collaboration: Work with cross-functional teams (Quality, Engineering, Production, Validation) on microbiological risk management and regulatory alignment.
Radiopharmaceutical-Specific Responsibilities
- Microbiology Oversight for Radiopharmaceuticals: Adapt and oversee environmental monitoring, bioburden, and sterility assurance strategies for rapid release and short half-life radiopharmaceutical products, including validated parametric/alternative release approaches.
- Technical Guidance for Radiopharmaceutical Suites: Advise on interventions in shielded isolators/hot cells. Ensure pragmatic contamination control solutions for frequent setups and short campaigns without compromising quality.
- Sampling Plan Design: Design and supervise practical sampling plans tailored for radiopharmaceutical products, ensuring robust data collection and contamination control despite operational constraints.
Qualifications
- Education: Bachelor’s degree (BSc) in Microbiology, Biological Sciences, or a related discipline is required.
- Relevant Experience: 5–8 years of experience supervising or leading teams within a laboratory or sterile/aseptic manufacturing environment, including experience with staff training, scheduling, and performance management.
- Significant hands-on work with environmental monitoring, contamination control, cleanroom operations, and regulatory compliance (EU Annex 1, cGMP, etc.).
- Specialized Experience: previous experience in radiopharmaceutical environments is an asset.
- Work in designated labs with radiological controls, contamination monitoring, and PPE requirements.
- Willingness and ability to work extended shifts, weekends, or holidays as needed. Occasional after-hours support for investigations, equipment alarms, or urgent testing.
- On-site presence in Hamilton, Ontario in classified areas, including work in isolators/hot cells with appropriate PPE and radiation safety protocols
- <5% travel required
At AstraZeneca, we foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies. You’ll join a collaborative, innovative community with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible. We’re committed to sustainability and equity, taking bold action on climate, access to healthcare, and disease prevention.
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Annual base salary for this position ranges from 86,266.40 to 113,224.65.
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.
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This advertisement relates to a current vacancy.
