QC Microbiology Supervisor

Job Description

BIOVECTRA, now a part of Agilent, is recognized as a leader in the contract development and manufacturing space of active pharmaceutical ingredients specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules production, including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharmaceutical and biotechnology manufacturing companies. 

BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics. 

The QC Microbiology Supervisor is responsible for providing technical and people leadership within the Quality Control Microbiology department in support of pharmaceutical manufacturing and testing operations. This role oversees microbiological activities including laboratory testing, complex investigations, method validation and verification, compliance programs, training, and continuous improvement initiatives while ensuring adherence to cGMP requirements and regulatory expectations.

The QC Microbiology Supervisor establishes departmental priorities and develops strategies that support operational objectives, regulatory compliance, inspection readiness, and the continued development of microbiology personnel. The role provides technical leadership across microbiological investigations, quality systems activities, laboratory compliance programs, and cross-functional initiatives while fostering collaboration with Manufacturing, Quality Assurance, Validation, Regulatory Affairs, and other site functions.

Key Responsibilities

• Lead, develop, and manage QC Microbiology personnel responsible for microbiological testing, investigations, environmental monitoring support, method validation activities, and laboratory compliance programs.
• Establish departmental priorities, assign resources, manage workloads, and develop short and long-term plans that align microbiology activities with operational requirements, quality commitments, and site objectives.
• Coach and develop team members through technical mentoring, training, performance management, development planning, and delegation of progressively more complex technical responsibilities.
• Lead and participate in complex microbiological investigations including contamination events, deviations, non-conformances, CAPAs, OOS/OOT results, and audit observations.
• Develop investigation strategies, perform root cause analysis, identify and characterize microorganisms associated with quality events, and ensure implementation of effective corrective and preventive actions.
• Design, execute, review, and approve microbiological method validations and verifications while ensuring activities are scientifically justified, appropriately documented, and aligned with regulatory requirements.
• Review and approve microbiology documentation including SOPs, protocols, validation reports, investigations, laboratory records, technical assessments, and training documentation.
• Ensure laboratory data, documentation, and records are accurate, complete, contemporaneous, and compliant with data integrity and cGMP requirements.
• Maintain an inspection-ready laboratory through effective management of quality systems, training programs, laboratory controls, and documentation practices.
• Provide technical expertise and training on microbiological methods, microbial identification, aseptic techniques, sterility testing, bioburden testing, and laboratory best practices.
• Support regulatory inspections, client audits, and quality assessments as a microbiology subject matter expert and ensure laboratory records and programs remain audit-ready.
• Collaborate with Manufacturing, Quality Assurance, Validation, Regulatory Affairs, and other stakeholders to resolve technical, quality, and compliance challenges.
• Lead or support continuous improvement initiatives that enhance laboratory performance, compliance, efficiency, and operational effectiveness.
• Provide regular updates to site leadership regarding microbiology program performance, investigation outcomes, compliance activities, resource requirements, risks, and departmental priorities.

Preferred Skills

• Strong knowledge of cGMP regulations and guidance documents including FDA, Health Canada, ICH, USP, Ph. Eur., and applicable ISO standards.
• Expertise in microbiological testing methods including Bioburden Testing (USP <61>), microbial identification, subculturing techniques, media preparation, and aseptic laboratory practices.
• Demonstrated ability to lead complex investigations, identify root causes, assess microbiological risk, and implement effective corrective actions.
• Strong technical writing, documentation review, and data analysis capabilities.
• Demonstrated ability to lead, coach, and develop technical personnel while fostering a culture of accountability, engagement, safety, and continuous improvement.
• Excellent written, verbal, and presentation skills with the ability to communicate technical information effectively to auditors, clients, regulators, management, and cross-functional teams.
• Strong organizational and project management skills with the ability to manage multiple priorities and compliance activities simultaneously.

Qualifications

Education

• Bachelor of Science in Microbiology or a related life sciences discipline required.
• Master of Science (MSc) or PhD in Microbiology or a related field is an advantage.

Experience

• Minimum 7 years of microbiology or related life sciences experience.
• Minimum 5 years of experience in a GMP or GLP regulated environment.
• Previous experience supervising, mentoring, or leading technical personnel.
• Experience writing and reviewing technical documents including SOPs, protocols, validation reports, and investigation reports.
• Experience supporting microbial contamination investigations in pharmaceutical manufacturing environments preferred.
• Experience serving as a subject matter expert during client audits and regulatory inspections preferred.
• Demonstrated experience in microbiological method validation, laboratory compliance programs, quality systems management, and regulatory inspection readiness.

Additional Details

This job has a full time weekly schedule.The full-time equivalent pay range for this position is $88,536.00 - $138,338.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory