Microbiologist

AstraZeneca; Hamilton; On-site; CAD 68,000 - 89,000; Full time

Benefits offered by this job

4 weeks’ paid vacation

Personal Days

Flex Benefits & Retirement Savings

Job summary

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is seeking a Microbiologist to lead environmental monitoring and contamination control in a GMP-regulated manufacturing environment in Hamilton, Ontario. You will develop and maintain microbiological control strategies, guide bioburden reduction, and ensure compliance with EU Annex 1 and global health authority expectations.

As SME for cleanroom operations, you will oversee EMPQ activities, investigations and CAPA, and provide training

Qualifications

• 5+ years of experience in pharmaceutical microbiology within a GMP-regulated cleanroom environment.
• Hands-on experience in environmental monitoring, contamination control, cleanroom operations, and regulatory compliance, including EU Annex 1 and cGMP.
• Bachelor's degree in microbiology or related discipline required.

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.

Skills

Environmental monitoring

Contamination control

Cleanroom operations

Regulatory compliance

GMP

Microbiology

Education

Bachelor's degree in Microbiology

Job description

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.

• 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.

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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.

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