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Scientist - Study Director Toxicology

2 months ago

Kitchener, Ontario, Canada Labstat International Inc. Full time

Job Summary:

Labstat International Inc. is seeking a highly skilled and experienced Toxicology Study Director to join our team. As a key member of our Toxicology department, you will be responsible for overseeing the analytical activities within the laboratory, ensuring the scientific quality of assays is not compromised during production, and implementing new Toxicology assays as needed.

Key Responsibilities:

  • Assay Performance and Life Cycle Management: Oversee assay performance, address assay deviations from set performance indicators, and manage the life cycle of assays.
  • Method Evaluation and Validation: Evaluate and validate new High-Throughput (HTP) methods, ensuring they meet the required standards.
  • Quality Control and Assurance: Maintain and update relevant Standard Operating Procedures (SOPs), ensure assay precision, accuracy, and reproducibility through Quality Control (QC) procedures, and lead Root Cause Analysis (RCA) for deviations and repeats.
  • Client Communication and Collaboration: Effectively communicate and coach the operations team, interact with clients on technical issues, and process analytical data.
  • Study Plan Design and Approval: Oversee the study plan design and approval, including any amendments, and oversee data collection, analysis, and reporting.
  • Protocol and Report Preparation: Prepare Study Plans/Study Protocols in consultation with the sponsor (client) and internal Management, and communicate analytical results to relevant stakeholders.

Requirements:

  • Education: M.Sc or PhD in Toxicology, Biology, Cellular Biology, or a related field.
  • Experience: Three (3) or more years of experience in a lab testing environment, with experience in nonclinical toxicology, in vitro assays, and flow cytometry.
  • Skills: Ability to work under strict deadlines in a fast-paced environment, strong drive to push forward, and working knowledge of Good Laboratory Practices (GLP) regulations.

What We Offer:

  • Competitive wages
  • RRSP Matching
  • TFSA's
  • Training Programs
  • Social events