Senior Research Scientist / Research Scientist
Responsible for developing and validating of bio-analytical methods for the bio-analytical laboratory and study sample analysis.
- Developing and support validation of bio-analytical methods under GLP and SOP guidelines.
- Assisting the lab management in evaluating external bio-analytical methods and working with external laboratories on collaborative projects.
- Following up on the recent progress and development in the area of biopharmaceutical sciences, specially in drug analysis/instrumentation and providing lab management (or other related departments) with suggestions on the future development of the analytical laboratory.
- Working with Senior Scientists
- Trouble shooting analytical instruments and assay procedures.
- Effectively transferring methods to the analysis group, and providing any relevant training to Analysts and LC-MS Operators.
- Preparing draft methods.
- Completely independent in operating and troubleshooting laboratory equipment.
- Able to carry out complete method development projects including conformational analysis.
- Attend scientific meetings and conferences, sharing knowledge gained with lab management and other laboratory staff
- Preparing scientific materials for presentations during lab meetings.
- Flexible to work in-shifts, necessary to ensure completion of assigned tasks.
- Supervise training of all the chemists to ensure that they are fully competent to conduct studies and provided with career development plans.
- Proactively monitor and control project execution to ensure all project objectives milestones are met within the agreed upon timelines.
- Tracked project schedule and keep team focused on critical path activities to ensure project success.
- Demonstrate leadership by motivating, and inspiring the chemists to keep the team moving toward successful completion.
- Perform other duties as assigned
Responsibilities in regards to the conduct of GLP and Non-GLP studies
In addition to General Responsibilities, the following are 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 and in compliance with the OECD Principles of Good Laboratory Practice.
- Work in a safe manner, complying with all relevant safety procedures.
- Exercise health precautions to minimize risk and to ensure the integrity of the study.
- Communicate to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study
- Minimum of a Bachelors degree in scientific field or equivalent.
- Knowledge of Health Canada regulatory requirements pertaining to Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and ICH Guidance Documents.
- Advanced experience in bio-analytical Method Development.
- Advanced knowledge of HPLC and LC-MS.
- Must have the ability to resolve technical problems in method development and validation.
- Proficient use of relevant computer software packages in a Windows environment (i.e. MS Word, Excel, and PowerPoint).
- Presentation of quality lab reports is essential.
- Ability to interact with all departments on a professional level.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills in the English language.
- Excellent attention to detail.
- Excellent analytical skills.
The position requires a minimum of 5 – 8 years of direct laboratory research experience in chromatography, LC-MS and bio-analysis.