Scientist - Study Director Toxicology

4 weeks ago

Kitchener, Ontario, Canada Labstat International Inc. Full time

Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Our organization includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. We provide laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.

We are currently seeking a Scientist – Study Director to join our growing team in Kitchener with our Labstat Division.

Key Responsibilities:

  • Oversee assay performance and address assay deviations from set performance indicators
  • Responsible for life cycle management of assays
  • Method evaluation/validation and troubleshooting
  • Maintain and update relevant SOPs
  • Maintain assay precision, accuracy, and reproducibility through appropriate QC procedures
  • Lead RCA for deviations and repeats
  • Effectively communicate and coach the operations team
  • Contribute to the implementation of new Toxicology assays as needed
  • Interact with clients on technical issues
  • Process analytical data

Primary Responsibilities:

  • Act as a subject matter expert for the various nonclinical assays
  • Oversee the day-to-day assay performance and ensure that any deviations are corrected in a timely manner
  • Successfully implement/validate and troubleshoot new HTP methods
  • Ensure that the scientific quality of the assays is not compromised during production
  • Follow QC procedures including QC charting and related measures related to Statistical Process Control (SPC)
  • Maintain assay precision, accuracy, and reproducibility through appropriate QC procedures.
  • Interact, supervise, and communicate effectively with peers
  • Work with the operations team to determine the required timelines for specific projects/analyses/method development.
  • Process analytical data and liaise with internal statistical department
  • Communicate analytical results to relevant stakeholders
  • Discuss technical inquiries with clients in a manner which is in keeping with company policy.
  • Lead RCA investigations and ensure that resolutions are identified in a timely manner
  • Perform duties of the Study Director for GLP Studies. Specifically, but limited to:
    • Ensure that the scientific, administrative, and regulatory aspects of the GLP study are controlled by coordinating the inputs from management, scientific/technical staff and the Quality Assurance program (QS).
  • Oversee the study plan design and approval, including any amendments, as well as overseeing data collection, analysis and reporting.
  • Prepare Study Plans/Study Protocols in consultation with the sponsor (client) and internal Management

Requirements:

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

What We Offer:

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

Labstat values a diverse workforce.

Labstat values Equal Opportunity and embraces diversity. Begin a dynamic and rewarding career by becoming a member of Labstat's team of professionals

Labstat is committed to meeting the accessibility requirements under the AODA and we invite applicants to contact us for specific requirements.

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