07 Sep
|
Auxilium Health
|
Ontario
07 Sep
Auxilium Health
Ontario
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
Robust 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.
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📌 Chemistry Laboratory Manager (Ontario)
🏢 Auxilium Health
📍 Ontario