Under the direction of the Senior Scientist, Bioanalytical-Protein Biosimilars Laboratory, the incumbent performs R&D related experiments and technical tasks for preclinical and clinical projects using ligand-binding and cell culture techniques.
- Performs complex bioanalytical method development. Conducts method validation in preparation for preclinical and clinical study sample analysis.
- Completes complex and highly specialized projects and studies related to Ligand-Binding and cell-based assays for pharmacokinetic, biomarker, and Immunogenicity.
- Assists and provide technical expertise in developing new methods.
- Coordinates/organizes/integrates resources (materials, activities, information, etc.) used in larger complex projects with flexibility to accommodate frequently changing priorities to meet established objectives
- Works independently, with broad latitude, in determining work activities to meet established objectives.
- Has excellent problem-solving skills. Solves complex and difficult problems where additional research is necessary. Shows innovation on an ongoing basis to assist management in solving problems related to any bioanalytical activities.
- Provides advice, guidance and advanced level training to other staff member prior to initiation validation and clinical sample analysis.
- Provides advanced troubleshooting and maintenance of the 96-well plate reader and washer. Provides a sound knowledge of laboratory equipment used for bioanalysis.
- Assists in developing and reviewing Standard Operating Procedures.
- Produces results and reports, in compliance with current applicable Standard Operating Procedures, for submission to Canadian and International regulatory agencies.
- Performs the job in a cost-effective manner and in compliance to GLP regulations.
- Works in a safe manner, complying with all relevant safety procedures and requirements.
- Exhibits good interpersonal skills, a professional attitude and motivation to produce consistently high-quality work.
- Performs other related duties as assigned by management.
- MSc degree in Immunology, Biochemistry, Molecular Biology, Cell Biology or related discipline with at least 3 years of relevant laboratory experience in biopharmaceutical industry.
- Advanced knowledge of pharmacokinetics (PK), Pharmacodynamics (PD), Biomarker, and Immunogenicity assays and reporting.
- Experience in laboratory basic techniques such as ELISA, cell culture, QPCR and flow cytometry.
- Knowledge of FDA, EMA, and Health Canada regulatory requirements pertaining to GLP and GCP.
- Experience in bioanalytical method development, validation, and sample analysis.
- Excellent knowledge of MS Word and Excel.
- Oral and written communication skills in English.
Job Type: Full-time
- laboratory experience in biopharmaceutical industry: 3 years (Preferred)
- Master's Degree (Preferred)