Company: BioPharma Services Inc.

Position Title: Principal Research Scientist

Salary Range: $80,000-$110,000

Job Class: Full Time

Work Location: Onsite (North York)

Position Summary

Under the direction of the Executive Director, Bioanalytical Lab Operations, the Principal Research Scientist performs special tasks related to analytical projects of high complexity and using LC-MS/MS. Acts as Principal Investigator for non-clinical projects (GLP).

Duties And Responsibilities

- Performs complex bioanalytical method development and method revision tasks on LC-MS/MS Sciex API 4000 & QTRAP 5500.
- Provide technical oversight to research scientists performing method development.
- Continually coordinate, organize, integrate resources used in large complex projects with flexibility to accommodate frequently changing priorities to meet established objectives.
- Assist in answering Deficiency Letters (DL) in a timely manner for regulatory agencies.
- As Principal Investigator ensures that the delegated phases of the non-clinical studies are conducted in accordance with applicable Principles of GLP.
- Responsibility for acknowledging all Study Deviations from the Study Plan or Standard Operating Procedures (SOPs) that originate at the test site, and for communication to the Study Director in a timely manner.
- Perform project feasibility study, write the bio-analytical methods and validation plans.
- Other duties under the Lab Manager requirement.

Responsibilities in regards to the conduct of GLP studies as Principal Investigator

- Approve the Bioanalytical Study Plan and any amendments to it with dated signature.
- Ensure QA personnel have a copy of the Study Plan, Bioanalytical Study Plan and any amendments in a timely manner and communicate effectively during the conduct of the study.
- Ensure that the Study Plan, Bioanalytical Study Plan and amendments and SOPs are available to study personnel.




- Ensure that the procedures specified in the Study Plan and Bioanalytical Study Plan are followed, assess and document deviations from the Plan and take appropriate corrective action if necessary.
- Ensure that all raw data generated are fully documented and recorded.
- Ensure that computerized systems used in the study have been validated.
- Sign and date the final Bioanalytical Report to indicate acceptance of responsibility for the validity of the data and the extent to which the study complies with Principles of Good Laboratory Practice.
- Ensure that after completion of the study, the study plan (bioanalytical), the final report, raw data and supporting materials are archived.
- Communicate with the Study Director (e.g. fax, email, etc) regarding all Study data and documentation.

Additional responsibilities in regards to the conduct of GLP and Non-GLP studies

- Generate analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
- Document and communicate any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
- Generate method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.
- Record raw data promptly and accurately in compliance with OECD Principles of Good Laboratory Practice.
- Work in a secure manner, complying with all relevant safety procedures.
- Exercise health precautions to minimize risk to self and ensure the integrity of the study.
- Communicate any relevant known health or medical condition to Laboratory Management so they can exclude you from operations that may affect the study.

Qualifications

- MSc or Ph.D. in Analytical Chemistry or a related field, with a minimum of 5 years of experience directly involved in the use and applications of LC-MS/MS.
- Or BSc/College Diploma in a related field with a minimum of 10 years of experience directly involved in the use and applications of LC-MS/MS.

📌 Principal Research Scientist (Toronto)
🏢 WELL Health Technologies Corp. (TSX: WELL)
📍 Toronto