Supervisor, Microbiology

Jubilant Radiopharma; Kirkland; Presencial; CAD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Jubilant Radiopharma seeks an experienced leader to oversee microbiology activities at our Kirkland facility. You will provide leadership for laboratory operations, regulatory compliance, scientific excellence, and team development while supporting continuous quality improvement initiatives.

You will play a key role in environmental monitoring, contamination control, microbiological investigations, and assessment of potential impacts on finished products and manufacturing environments.

Formación

• Bachelors or Masters in Microbiology or closely related discipline.
• Ten (10) years of relevant experience in a pharmaceutical microbiology laboratory.
• Experience working in a sterile environment.
• Minimum five (5) years of supervisory experience in a pharmaceutical microbiology laboratory.
• Excellent knowledge of environmental monitoring programs.
• Experience managing aseptic operations for injectable sterile products.
• Strong knowledge of microbiology laboratory operations and instrumentation.
• In-depth knowledge of cGMP regulations applicable to sterile parenteral products in Canada, the United States, and the European Union.
• Knowledge of microbiology analytical development, method transfer, and validation.
• Proficiency with Microsoft Office and SAP.
• Bilingual in French and English. Proficiency in English is essential since the position requires interaction with regulatory agencies outside Quebec (e.g., the FDA)
• Strong interpersonal, organizational, communication, and technical writing skills.
• Demonstrated ability to manage multiple priorities and concurrent projects.

Responsabilidades

• Lead the day-to-day operations of the microbiology laboratory and support the development of a high-performing team.
• Ensure analytical accuracy and compliance with GMP, cGMP, and applicable regulatory requirements.
• Write, review, and approve impact assessments, protocols, reports, and microbiological procedures.
• Support microbiological method development, transfer, and validation activities.
• Manage laboratory equipment and ensure proper qualification, calibration, and maintenance.
• Establish, maintain, and continuously improve the Environmental Monitoring (EM) program in accordance with internal and regulatory standards.
• Oversee testing of finished products, raw materials, and stability samples.
• Serve as the microbiology subject matter expert during regulatory inspections and audits (Health Canada, FDA, EMA).
• Lead or support investigations related to Out-of-Specification (OOS) results, quality events, and contamination issues.
• Identify root causes and implement effective corrective and preventive actions.
• Ensure personnel qualification for cleanroom access and compliance with microbiological best practices.
• Provide technical support to Production, Quality Assurance, and Validation teams.
• Support new product introductions, site transfers, and continuous improvement initiatives.
• Review microbiological trends and generate reports to support data-driven decision making.
• Participate in recruiting, training, and developing microbiology team members.

Conocimientos

Leadership

Regulatory compliance

GMP/cGMP knowledge

Environmental monitoring

Investigations

Quality improvement

Technical writing

Cross-functional collaboration

Educación

B.Sc./M.Sc. in Microbiology

Herramientas

Microsoft Office

SAP

Descripción del empleo

Career Opportunities: Supervisor, Microbiology (1928)

AtJubilant Radiopharma, we help healthcare professionals deliver essential patient care through radiopharmaceutical solutions. Our team is driven by quality, safety, innovation, and collaboration. We foster an environment where everyone can contribute, grow, and make a meaningful impact.

Role Overview

We are seeking an experienced leader to oversee microbiology activities at our Kirkland facility. In this role, you will provide leadership for microbiology laboratory operations, regulatory compliance, scientific excellence, and team development while supporting continuous quality improvement initiatives.

You will play a key role in environmental monitoring, contamination control, microbiological investigations, and the assessment of potential impacts on finished products and manufacturing environments.

Key Responsibilities

• Lead the day-to-day operations of the microbiology laboratory and support the development of a high-performing team.
• Ensure analytical accuracy and compliance with GMP, cGMP, and applicable regulatory requirements.
• Write, review, and approve impact assessments, protocols, reports, and microbiological procedures.
• Support microbiological method development, transfer, and validation activities.
• Manage laboratory equipment and ensure proper qualification, calibration, and maintenance.
• Establish, maintain, and continuously improve the Environmental Monitoring (EM) program in accordance with internal and regulatory standards.
• Oversee testing of finished products, raw materials, and stability samples.
• Serve as the microbiology subject matter expert during regulatory inspections and audits (Health Canada, FDA, EMA).
• Lead or support investigations related to Out-of-Specification (OOS) results, quality events, and contamination issues.
• Identify root causes and implement effective corrective and preventive actions.
• Ensure personnel qualification for cleanroom access and compliance with microbiological best practices.
• Provide technical support to Production, Quality Assurance, and Validation teams.
• Support new product introductions, site transfers, and continuous improvement initiatives.
• Review microbiological trends and generate reports to support data-driven decision making.
• Participate in recruiting, training, and developing microbiology team members.

Qualifications

• B.Sc. or M.Sc. in Microbiology or a closely related discipline.
• Minimum ten (10) years of relevant experience in a pharmaceutical microbiology laboratory.
• Experience working in a sterile environment.
• Minimum five (5) years of relevant supervisory experience within a pharmaceutical microbiology laboratory.
• Excellent knowledge of environmental monitoring programs.
• Experience managing aseptic operations for injectable sterile products.
• Strong knowledge of microbiology laboratory operations and instrumentation.
• In-depth knowledge of cGMP regulations applicable to sterile parenteral products in Canada, the United States, and the European Union.
• Knowledge of microbiology analytical development, method transfer, and validation.
• Proficiency with Microsoft Office and SAP.
• Bilingual in French and English. Proficiency in English is essential since the position requires interaction with regulatory agencies outside Quebec (e.g., the FDA)
• Strong interpersonal, organizational, communication, and technical writing skills.
• Demonstrated ability to manage multiple priorities and concurrent projects.