Microbiologist

Purpose of the Role

In addition to performing the core duties of a microbiology laboratory technician, the incumbent supports the Microbiology Laboratory Supervisor by ensuring the execution and coordination of analytical activities, as well as the review and release of analytical records. The role includes writing and evaluating investigations or assisting technicians with these tasks.

Acts as the delegated authority for the Microbiology Supervisor during their absence.

Main Responsibilities

• Under the supervision of the Laboratory Supervisor, coordinates short-term analytical activities related to raw materials, finished products, stability samples, and the plant environment, based on priorities and deadlines.
• Coordinates change requests related to the Quality Control Microbiology laboratory.
• Ensures communication between the Microbiology group and other internal departments (Chemistry, Manufacturing, Packaging, Stability, Planning, Quality Assurance, and CMC).
• Coordinates the final review of analytical records and approval of the microbiology “stage” in LIMS.
• Ensures required documentation is complete and compliant with GMPs.
• Occasionally participates in writing equipment qualification protocols.
• Uses experience to support resolution of analytical issues in collaboration with technicians, the Supervisor, and the Department Head.
• Writes method validation protocols and reports and participates in their execution.
• Coordinates and distributes analytical activities related to production and the stability program according to priorities and timelines.
• Performs microbiological analyses when required.
• Coordinates instrument calibration activities.
• Writes and evaluates laboratory investigations in collaboration with the Supervisor and Department Head and assists technicians with these tasks.
• Writes, reviews, and updates specifications, methods, and procedures.
• Participates in quality control operational improvement initiatives.
• May participate in internal audits and audits of external analytical service providers.
• May serve as a subject matter expert during regulatory agency or client audits.
• May act as the laboratory Biosafety Officer.
• When performing Supervisor Delegate duties, the Microbiologist may not carry out analytical testing work.

Management of Material Resources (Budget)

• May approve routine purchase orders according to current accounting rules.
• May send materials for external analysis.
• No budget responsibility.

Required Knowledge and Skills

a) Education

Bachelor’s degree in Microbiology or equivalent

b) Languages

French and English

c) Experience and Specific Knowledge

Minimum 5 years of experience in microbiological analyses within a pharmaceutical laboratory

d) Technical Skills

Knowledge of technologies and equipment in the field
Pharmacopoeial references (USP, EP, BP)
GMP regulations (Health Canada, FDA, European standards)
Document management
Laboratory instrumentation and metrology
Laboratory information management systems

Priority management
Strong interpersonal skills and ability to work in a team
Customer focus and respect for deadlines
Results-oriented with attention to detail
Ability to analyze, interpret, and produce reports

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.