Team Leader, Microbiology

Scientific Search; Kirkland; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading global pharmaceutical CMO is seeking a Team Leader in Microbiology to oversee QC activities in Montreal. The successful candidate will coordinate testing, ensure compliance with regulatory standards, and lead method validation efforts. This mid-senior level role requires strong microbiological expertise and leadership skills, along with proficiency in both French and English.

Qualifications

• At least 3 years of microbiology lab experience, preferably in QC or R&D.
• Strong knowledge of USP, EP, BP, and cGMP standards.
• Excellent report writing skills.

Responsibilities

• Coordinate QC activities related to microbiological testing.
• Plan and execute technical transfer of new products.
• Perform microbiological analyses on samples.

Skills

Microbiological techniques

Analytical skills

Leadership

Organizational skills

Bilingual (French and English)

Education

D.E.C. or B.Sc. in Microbiology

Tools

Microsoft Office

SAP

Electronic Data Acquisition Systems

Job description

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Team Leader, Microbiology

(Onsite in Montreal, CA)

Company Profile:

Global Pharmaceutical CMO

What You Can Expect To Be Doing

• Coordinate QC activities related to the Microbiology laboratory to ensure microbiological testing of utilities, raw materials, in-process, finished drug products, and stability samples meet customer specifications and regulatory standards (HPFBI, FDA, EU, etc.).
• Plan and execute the technical transfer of new products to the QC Microbiology laboratory, providing staff with technical assistance and GMP-compliant training.
• Schedule and coordinate analyses performed by analysts and external laboratories efficiently and timely.
• Develop and execute method validation/verification protocols for the Microbiology laboratory.
• Perform microbiological analyses on samples, adhering to test methods, protocols, and cGMP standards.
• Provide technical support and project updates to internal and external customers.
• Maintain accurate records of test results, instrument readings, and observations, ensuring data integrity and traceability.
• Notify supervisors of any OOS, OOT, or irregular results, initiate investigations, and assist in root cause analysis.
• Prepare trending reports for the Microbiology laboratory.
• Lead or participate in projects such as method and instrumentation validation, troubleshooting, and training.
• Contribute to SOP drafting and revisions collaboratively with the QC team.
• Participate in training programs and review analyst performance periodically.
• Improve departmental efficiency regarding CAPA, investigations, SOPs, NPIs, and documentation.
• Serve as a microbiology subject matter expert for analysis, pharmacopeia requirements, and microorganism identification.
• Perform additional tasks as assigned by management.

Education And Experience

• D.E.C. or B.Sc. in Microbiology or a related field.
• At least 3 years of microbiology lab experience, preferably in QC or R&D, with solid method validation/transfer/verification experience.
• Strong knowledge of USP, EP, BP, and cGMP standards.
• Proficiency in microbiological techniques: Gram staining, API, Vitek, endotoxin testing, sterility, microbial counts.
• Experience testing various dosage forms and troubleshooting methods.
• Excellent report writing skills.
• Computer skills: Microsoft Office, SAP, Electronic Data Acquisition Systems.
• Bilingual in French and English; proficiency in English is essential.
• High autonomy, analytical skills, and rigor.
• Leadership, organizational skills, and teamwork experience.

To learn more, contact [e-mail] and reference job# 19343.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Information Technology
• Industry: Pharmaceutical Manufacturing