Principal Research Scientist at WELL Health Technologies Corp. (TSX: WELL)

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 developmentContinually coordinates, organizes, integrates resources used in large complex projects with flexibility to accommodate frequently changing priorities to meet established objectivesAssists 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.Performed project feasibility study, written the bio-analytical methods and validation plans.Other duties under the Lab Manager requirement.

Approving the Bioanalytical Study Plan and any amendments to it by dated signature.Ensuring that the Quality Assurance personnel have a copy of the Study Plan, Bioanalytical Study Plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study.Ensuring that Study Plan, Bioanalytical Study Plan and amendments and Standard Operating Procedures are available to study personnelEnsuring that the procedures specified in the Study Plan, Bioanalytical Study Plan are followed, and assess and document the impact of any deviations from the Study Plan and Bioanalytical Study Plan on the quality and integrity of the study, and take appropriate corrective action if necessary.Ensuring that all raw data generated are fully documented and recorded.Ensuring that computerized systems used in the study have been validated.Signing and dating the final Bioanalytical Report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice.Ensuring that after completion (including termination) of the study, the study plan (bioanalytical), the final report, raw data and supporting materials are archived.Communicating with the Study Director (e.g. fax, e-mail, etc) regarding all Study data and documentation.

In addition to General Responsibilities, the following are additional responsibilities in regards 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).Generates method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.Works in a safe manner, complying with all relevant safety procedures.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

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

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