Research Scientist/Principal Research Scientist

Job summary

The role involves performing complex bioanalytical method development and revision using LC-MS/MS for small molecules and biologics. It also requires providing technical oversight to R&D chemists and ensuring compliance with GLP and regulatory standards.

Job details

Company: BioPharma Services Inc. Position Title: Principal Research Scientist Salary Range: $80,000-$100,000 Job Class: Full Time Work Location: Onsite (North York) Position Summary: Under the direction of the Executive Director, Bioanalytical Laboratory Operations, performs special tasks related development of bioanalytical projects of high complexity and using LC-MS/MS. Duties and Responsibilities: * Performs complex bioanalytical method development and method revision tasks, on LC-MS/MS Instruments. * Expert in method development of small molecules in different biological matrices of animals and humans with different extraction techniques. * Capable of developing method for biologics using LCMS/MS. Which includes, large molecules, ADCs, bispecific compounds, Small peptides and ceramides. * Adjust chromatographic and MS conditions to improve sensitivity, selectivity, peak shape, and robustness. * Subject Matter Expert(SME) for bioanalytical analysis of small molecules LCMSMS analysis. * Evaluate and minimize matrix effects, carryover, interferences, and variability. * Establish and manage internal standards and assess potential co‑medication/endogenous interferences. * Plan and support method validation (accuracy, precision, linearity, selectivity, stability, dilution integrity, etc.). * Document method development, optimization, and validation work clearly in protocols and reports. * Provide technical oversight during routine sample analysis using developed/validated methods. * Review chromatograms and data integration, investigate atypical results, and recommend corrective actions. * Provide technical oversight to R&D chemists (and validation/production chemists) performing method development. * Provides technical training to new chemists and when corrective/preventative action are required in response to technical challenges and failures. * Continually coordinate, organize, and integrate resources used in large complex projects with flexibility to accommodate frequently changing priorities to meet established objectives. In addition to General Responsibilities, the following are additional responsibilities regarding 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. * Document and communicate 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 for 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 advanced-level use and applications of LC-MS/MS. Or * BSc. /College Diploma in Analytical Chemistry or a related field with a minimum of 10 years of related experience directly involved in the advanced-level use and applications of LC-MS/MS.

What you’ll do

The role involves performing complex bioanalytical method development and revision using LC-MS/MS for small molecules and biologics. It also requires providing technical oversight to R&D chemists and ensuring compliance with GLP and regulatory standards.

Requirements

Candidates must have a postgraduate degree with at least 5 years of LC-MS/MS experience, or a bachelor's degree with at least 10 years of experience. Expertise in bioanalytical method development for various biological matrices is essential.

Listed skills

• Validation · Preferred
• Analytical · Preferred
• Technical · Preferred
• precision · Preferred
• analysis · Preferred
• procedures. · Preferred
• Health · Preferred
• Compliance · Preferred
• management · Preferred
• Accuracy · Preferred
• Development · Preferred
• Integration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• LC-MS/MS
• Bioanalytical Method Development
• Small Molecule Analysis
• Biologics Analysis
• Method Validation
• Chromatography
• Matrix Effect Evaluation
• GLP Compliance
• Technical Oversight
• Data Integration
• SOP Documentation
• Regulatory Reporting

Job areas

• Science & Research
• Healthcare
• Engineering

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