Job Description

Position Summary:

Supports VP, Laboratory Operations (or designate) in the effective and efficient operation of the laboratory facility, to ensure productivity is maximized, timelines are achieved maintaining high quality of work.

Duties and Responsibilities:

Provide direct supervision, mentorship, and performance management of laboratory personnel, ensuring staff are adequately trained, competent, and compliant with SOPs and regulatory requirements. Coordinate staffing assignments to align with project timelines, workload balance, and individual development goals. Foster a culture of accountability, safety, and continuous improvement through regular feedback, training initiatives, and team meetings. Conduct regular performance evaluations and support career development through coaching and development planning. Manage onboarding and ongoing training of new and existing laboratory staff to ensure operational readiness and compliance. Track upcoming projects and maintains laboratory schedule (R&D, validation and studies) including resource requirements (instruments and staff) Interact with R&D-, Production-, and Reporting/QC-groups to establish timelines for project management group (preliminary data, final data, and bioanalytical reports). Maintain schedule for assessment of long-term stability determinations to support study samples analysis. Prepare daily, weekly and monthly laboratory schedules and tracks production metrics. Track R&D/Validation projects for annual SR&ED tax credit fillings. Manages lab supplies required for ongoing and R&D and production and balances supply needs with project schedule. Work with vendors to negotiate and improve laboratory service contracts Assess laboratory workflow and make recommendations for space upgrades and renovations in collaboration with facility management. Manage the system for calibration, maintenance and cleaning of all laboratory equipment and maintenance of records. Manage sample shipment/receiving and maintenance of records; contacts project managers, and clinical groups to resolve discrepancies in a timely manner Respond to out of specification freezer alarms (during regular working hours and out of hours (evenings and weekends. Maintain high standards of internal and external customer service by keeping regular communication with all stakeholders. Demonstrate excellent written and oral communication skills. Assists in developing and reviewing Standard Operating Procedures. Performs the job in a cost-effective manner. Performs the job according to an approved Protocols and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements. Participate in audits performed by external auditors, i.e. Canadian HPFBI, US FDA, EU/AU agencies. Works in a safe manner, complying with all relevant safety procedures and requirements. Performs other related duties assigned by Lab Management.

In addition to General Responsibilities, the following are additional responsibilities in regard to the conduct of GLP and Non-GLP studies:

Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements. Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies). Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice. Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.

Qualifications:

Technical college degree in chemistry-related field * A minimum of 5 years of experience in laboratory operations environment