Microbiologist

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

Benefits offered by this job

Flex Benefits

4 weeks paid vacation

Personal Days

Job summary

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is seeking a Microbiologist in Hamilton, Ontario. The role provides SME support for contamination control and environmental monitoring within a regulated pharmaceutical manufacturing environment.

Responsibilities include leading EMPQ activities, reviewing procedures, and guiding cross-functional teams to ensure compliance with EU Annex 1 and cGMP, while maintaining product quality and patient safety.

Qualifications

• Bachelor’s degree in microbiology or a related field.
• 5+ years of pharmaceutical microbiology in a GMP cleanroom.
• Experience with EU Annex 1 and regulatory compliance.

Responsibilities

• Contamination control and environmental monitoring in pharmaceutical manufacturing.
• Own the site environmental monitoring program for classified areas.
• Interpret environmental monitoring trends, assess excursions and risks to product, process and facility control.
• Lead EMPQ activities for cleanrooms, equipment, utilities and processes; ensure study design and documentation.
• Investigations and CAPA for excursions, contamination events or deviations; root cause analysis.
• Bioburden control guidance; routine monitoring and data interpretation.
• Document and revise GMP procedures; ensure inspection readiness.
• Provide microbiological input into change controls, risk assessments, and qualification activities.
• Train operations, quality and support teams; influence site practices through scientific decisions.
• Support qualification activities for facilities and utilities.

Skills

Environmental monitoring

Contamination control

GMP compliance

Cleanroom operations

Education

Bachelor's degree in microbiology

Job description

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:

TheMicrobiologistprovides technical leadership and subject matter expertise inenvironmental monitoring, contamination control, and cleanroom process designwithin a regulated pharmaceutical manufacturing environment. The role supports the development, implementation, maintenance, and continuous improvement of microbiological control strategies to ensureproduct quality, patient safety, and compliancewith global regulatory requirements, includingEU Annex 1, GMP, and applicable health authority expectations.

This position serves as anSMEin contamination control and cleanroom operations, with responsibility for assessing the microbiological impact of environmental excursions, leadingEnvironmental Monitoring Performance Qualification (EMPQ)activities, authoring and revising procedures, and providing technical guidance onbioburden controland 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 disciplinerequired.
• 5+ yearsof experience in pharmaceutical microbiology within aGMP-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, includingEU Annex 1andcGMP.

Preferred Experience:

• Experience inradiopharmaceutical environmentsis an asset.
• Work Requirements: Willingness to work shifts, weekends, holidays, and occasional after-hours support as needed.

Location: On-site presence inHamilton, Ontario, including work in classified areas, isolators, and hot cells using appropriate PPE and radiation safety protocols.

Travel: Less than5%travel required.

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.