Senior Scientist, Chemistry

2 weeks ago

Montréal QC, Canada Brunel Full time

Senior Scientist - LBA (Anti Drug Antibody) Montreal, QC

The Senior Scientist will be assigned to projects in the LBA department relating to Anti Drug Antibody discovery and research. The Scientist will ensure the overall integrity/quality of assigned studies. The Senior Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects and have Direct Reports.

Will be assigned to assay development, qualification, validation and production expert in multiple assay types and mentor for more junior staff. Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction
Assigned to studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
For validations and sample analysis the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification, validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices;
Manage project and order appropriate material, as needed
Provide QC support on studies assigned to other team members in laboratory based on training and competencies.
Perform data batch review, perform multi-batch trend analysis, complete documentation as required by tracking deviations, events and reports of non-compliance and review or approved Memo to File or SOP/Protocol/Study Plan deviations;
Provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate;
Review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed;
Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts work. Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
Participate in meetings with clients, conferences and scientific outreach
Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies
Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures;

University or College degree in Chemistry, Biochemistry, Immunology or applicable field.
Knowledge of regulatory agency guidelines, must have a deep understanding of general SOPs and have an excellent knowledge of GCP/GLP regulations.
Exceptional organizational skills, highly flexible, sense of urgency, excellent troubleshooting skills, client-oriented, and attentive to details.
Good communication skills, both written and verbal in French & English (preferred)

Finding the next step in your career can be a full-time job in itself. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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