Scientist - Study Director Toxicology

2 months ago

Kitchener, Canada Labstat International Inc. Full time

Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group 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. Certified Group provides 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 looking for a Scientist – Study Director to join our growing team in Kitchener with our Labstat Division

As a result of our continuing growth, Labstat has the following employment opportunity available:

As an Operations Scientist you are responsible for multiple in vitro assays within the Toxicology department. More specifically, you are the subject matter expert with respect to assay performance and life cycle management. You work with the operations team to standardize the assay workflows, analyze assay trends and work to continuously improve the assays. In addition, you will be responsible for analyzing and interpreting the assay data as well as preparing client protocols and reports.

The Scientist is responsible for the analytical activities within the laboratory. This includes:

  • Overseeing assay performance and addressing 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 of the job:

  • 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

Other duties as assigned

Minimum Qualifications:

  • 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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