Microbiologist 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. Position Overview: The Microbiologist provides technical leadership and subject matter expertise in environmental monitoring, contamination control, and cleanroom process design within a regulated pharmaceutical manufacturing environment. The role supports the development, implementation, maintenance, and continuous improvement of microbiological control strategies to ensure product quality, patient safety, and compliance with global regulatory requirements, including EU Annex 1, GMP, and applicable health authority expectations. This position serves as an SME in contamination control and cleanroom operations, with responsibility for assessing the microbiological impact of environmental excursions, leading Environmental Monitoring Performance Qualification (EMPQ) activities, authoring and revising procedures, and providing technical guidance on bioburden control and regulatory expectations.

Responsibilities

Contamination Control and Environmental Monitoring: Provide SME support for contamination control and environmental monitoring in pharmaceutical manufacturing. Program Ownership: Design, implement, maintain, and improve the site environmental monitoring program for classified manufacturing areas, including viable and particulate monitoring, sampling plans, alert/action levels, data review, and trending. Trend and Excursion Assessment: Interpret environmental monitoring trends, assess excursions and out-of-limit results, and evaluate microbiological risks to product, process, and facility control. EMPQ Leadership: Lead and support EMPQ activities for new and existing cleanrooms, equipment, utilities, and processes, ensuring sound study design, execution, documentation, and interpretation. Investigations and CAPA: Lead or support investigations related to environmental excursions, contamination events, atypical results, utility monitoring failures, and process deviations, including root cause analysis and CAPA. Bioburden Oversight: Provide technical guidance on bioburden control strategies, routine monitoring, sampling rationale, method suitability, and data interpretation. Documentation and Compliance: Author and revise GMP procedures and technical documents, while ensuring microbiological programs remain compliant and inspection ready. Change Control and Risk Assessment: Provide microbiological input into change controls, risk assessments, and qualification activities involving facilities, utilities, equipment, materials, and manufacturing processes. Training and Cross-Functional Support: Deliver technical coaching and training to operations, quality, and support teams, and influence site practices through scientific, risk-based decision-making. Cleanroom Qualification and Sampling Plans: Support cleanroom qualification and requalification activities and develop scientifically justified environmental and bioburden sampling plans. Essential Requirements/Skills: Minimum bachelor’s degree in microbiology, biological sciences, or a related discipline required. 5+ years of experience in pharmaceutical microbiology within a GMP-regulated cleanroom environment, with strong emphasis on environmental monitoring and contamination control. Hands-on experience in environmental monitoring, contamination control, cleanroom operations, and regulatory compliance, including EU Annex 1 and cGMP. Preferred

Experience

Experience

in radiopharmaceutical environments is an asset. Work

Requirements

Willingness to work shifts, weekends, holidays, and occasional after-hours support as needed. Location: On-site presence in Hamilton, Ontario, including work in classified areas, isolators, and hot cells using appropriate PPE and radiation safety protocols. Travel: Less than 5% travel required. 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 ⠀ 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.