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.

Responsibilities

• Will be assigned to assay development, qualification, validation and production expert in multiple assay types and mentor for more junior staff. Could have associate scientists and/or scientist I and II reporting to them
• 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;
• Manage timelines and scheduling commitments
• 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. Support and mentor other team members based on expertise,
• Responsible for troubleshooting issues within the studies and be able to resolve them independently via development of appropriate procedure.
• Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
• To write, review and updated method SOP as needed
• 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;

Requirements

• University or College degree in Chemistry, Biochemistry, Immunology or applicable field.
• At least 3-5 years of relevant experience in regulated clinical and/or preclinical studies, preferably in a CRO environment and with Anti Drug Antibody experience
• 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.
• Must be able to easily read and understand study plans and protocols, have the ability to coach/mentor people,
• Good communication skills, both written and verbal in French & English (preferred)

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