Chemistry Laboratory Manager

Auxilium Health; Oshawa; On-site; CAD 90,000 - 130,000; Full time

Job summary

Stratum Analytical is seeking a Chemistry Laboratory Manager to lead the day-to-day operations of the chemistry lab and ensure alignment with ISO 9001, ISO 17025, and Health Canada requirements.

You will oversee personnel, project planning, and resource allocation, with a focus on HPLC and LC–MS/MS testing, method development, validation, and troubleshooting to support growth.

Qualifications

• Bachelor degree in Chemistry or Biochemistry or equivalent experience.
• Minimum 5 years in analytical chemistry laboratory with hands-on HPLC and LC–MS/MS.
• Strong knowledge of ISO 9001 and ISO 17025 quality systems and Health Canada GMP.
• Experience with method development, validation, verification, and troubleshooting.

Responsibilities

• Oversee day-to-day operations of the chemistry lab and ensure compliance with regulatory and quality standards.
• Develop and implement SOPs; enforce QC procedures and accuracy of test results.
• Lead projects with resource planning, budgeting, and on-time delivery within scope.
• Mentor staff, conduct performance reviews, and drive professional development.
• Coordinate with QA, Operations, and lab teams to support continuous improvement.
• Drive CAPA and root cause analysis; lead instrument qualification and validation.

Skills

Leadership & Mentoring

Data management software

Regulatory knowledge

Education

B.Sc. in Chemistry/Biochemistry

Quality management certification

Tools

HPLC

LC-MS/MS

Mass spectrometry

Job description

JOB DESCRIPTION

POSITION

Chemistry Laboratory Manager

COMPANY AND LOCATION

Stratum Analytical, 44 Richmond St. W Suite 101

EMPLOYMENT TYPE

Permanent, full time

HOURS WORKED

37.5 hours/week

DIRECT REPORTS

Yes

POSITION SUMMARY

The Chemistry Laboratory Manager is responsible for leading the day-to-day operations of the chemistry laboratory while ensuring compliance with applicable regulatory, quality, accreditation, and safety requirements. This role oversees laboratory personnel, project planning, workflow management, resource allocation, and continuous improvement initiatives to support business objectives. The successful candidate will work closely with Quality Assurance, Operations, and laboratory teams to ensure projects are delivered on time, within scope, and in accordance with ISO, GMP, and Health Canada requirements.

A key responsibility of this position is providing technical leadership in analytical chemistry, with a strong focus on HPLC and LC-MS/MS (mass spectrometry) testing, method development, validation, and troubleshooting. The Laboratory Manager will be responsible for leading the implementation and onboarding of mass spectrometry capabilities within the laboratory, including instrument selection, qualification, method transfer and validation, workflow development, staff training, and ongoing operational support. The role requires a balance of hands‑on technical expertise, project management, and leadership to ensure the laboratory remains compliant, efficient, and positioned for future growth.

GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS

Operational Management

• Oversee daily lab operations to ensure a productive and efficient work environment
• Develop and implement standard operating procedures (SOPs) for lab activities
• Establish and enforce quality control procedures to ensure accuracy and precision of test results
• Perform other duties as required
• Scheduling: Assign testing or kit assembly to analysts based on expertise and availability as well as finding opportunities for batch testing to increase efficiency
• Communicate with the customer care team on delays or issues in sample processing
• Oversee and monitor long‑term projects to ensure milestones, timelines, budgets, and strategic objectives are met

Team Management

• Coordinate and review laboratory staffing, schedules, and task assignments with the Associate Director of Operations to ensure optimal resource utilization, operational efficiency, and project delivery
• Lead laboratory projects by developing project plans, monitoring progress, managing resources, and ensuring deliverables are completed on time, within budget, and in compliance with applicable accreditations and regulatory requirements
• Mentor and develop laboratory personnel through training, competency assessments, technical guidance, and ongoing professional development to ensure high‑quality and compliant laboratory operations
• Collaborate with the Inventory Specialist to ensure there is supply redundancy and the most cost‑effective consumable sourcing is selected
• Foster a collaborative and positive work environment
• Conduct regular meetings to gather employee feedback
• Review team member performance and assist with the probationary and annual reviews of the team
• Assist with handling any conflicts within the team in collaboration with the Director of Operations and HR
• Identify opportunities for process improvements and drive initiatives to enhance laboratory efficiency and accuracy
• Lead root cause analysis and corrective/preventive action (CAPA) processes
• Negotiate current employees’ job responsibilities and manage their time to achieve project goals

Data Management

• Maintain accurate and complete records of laboratory activities, including test results, equipment calibration, and corrective actions
• Review and approve Work Orders, data, and reports

Safety and Compliance

• Supervise chemistry and physical testing laboratory activities and ensure relevant personnel comply with all health and safety regulations as well as accreditations/licensing/regulatory standards
• Provide training and guidance to laboratory staff on quality procedures and accreditations/licensing/regulations (Health Canada, ISO 9001, ISO 17025)
• Promote a culture of quality and accountability throughout the laboratory
• In response to findings from regulatory inspections, coordinate responsibilities and ensure completion of tasks.
• Develop, implement, and maintain a comprehensive QMS in accordance with ISO 9001 standards
• Ensure all laboratory processes and procedures align with ISO 9001 and 17025 requirements
• Monitor and improve the effectiveness of the systems through regular audits and assessments

Analytical Testing

• Demonstrate expertise in a range of chemical testing techniques, including titrations, stability‑indicating HPLC analysis, pH analysis, viscosity assessment, and particulate analysis
• Lead the implementation, qualification, and routine operation of LC‑MS/MS instrumentation
• Provide technical mentorship and training to laboratory personnel in chromatographic and mass spectrometry techniques
• Stay current with industry technology and instruments, with a focus on HPLC analytical chemistry applications in pharmaceuticals
• Support all laboratory workstations as needed, providing backup support as required
• Review and approve analytical data, validation protocols, reports, and investigations
• Troubleshoot technical, formulation, and processing issues

QUALIFICATIONS

Regulatory

• Strong knowledge of ISO 9001 and 17025 standards and quality management principles
• Strong knowledge of the Health Canada Controlled Drugs and Substances Act and GMP

Education

• A B.Sc. degree in a relevant scientific field (e.g., Chemistry or Biochemistry) or relevant industry experience
• Certification in quality management is an asset

Experience

• Minimum 5 years of experience in an analytical chemistry laboratory, including significant hands‑on experience with HPLC and LC‑MS/MS instrumentation
• Demonstrated experience in analytical method development, validation, verification, and troubleshooting
• Experience with lab equipment maintenance and troubleshooting
• Experience with laboratory instrumentation and analytical techniques

Skills

• Strong organizational and time management skills
• Proficiency in data management and analysis software
• Knowledge of safety and regulatory standards in a research setting

Personal Attributes

• Excellent leadership and team management skills
• Strong communication and interpersonal skills
• Strong organizational skills including attention to detail and multi‑tasking skills
• Detail oriented with a commitment to accuracy and data integrity
• Excellent written and verbal communication skills
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast‑paced environment
• Forward looking thinker, who actively seeks opportunities and proposes solutions
• Detail‑oriented and methodical
• Ability to work independently and as part of a team
• Problem‑solving skills and ability to handle multiple tasks

SPECIFIC WORKING CONDITIONS OR PHYSICAL REQUIREMENTS:

• Work is primarily performed in a laboratory setting
• May require occasional evening or weekend work to meet project deadlines
• Physical requirements include standing for extended periods and handling laboratory equipment and materials
• Fine motor skills and manual dexterity for tasks such as pipetting, handling small samples, and operating laboratory equipment
• Should be comfortable wearing appropriate PPE, such as lab coats, gloves, safety glasses, and respirators when necessary
• Proper handling of chemicals and adherence to safety protocols
• Working with biohazardous materials and hazardous chemicals

DISCLAIMER: The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

Stratum Analytical is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.

As our company continues to grow, we're excited to welcome a Chemistry Laboratory Manager to our team.