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Scientist I

2 months ago

Montréal QC, Canada Brunel Full time

Scientist I (LBA - Anti Drug Antibodies)Montreal, QCIntroductionThe Scientist will be assigned to projects based on scientific competency and training, but will focus on Anti Drug Antibodies. The Scientist will ensure the overall integrity/quality of assigned studies. The Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects.ResponsibilitiesAssigned by management on 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 PrincipalInvestigator and is the first point of contact for PM and/or clients for laboratory services andwill 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 PracticesManage project and order appropriate material, as neededWhen applicable, provide QC support on studies assigned to other team members in laboratory based on training and competencies.When applicable, 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 approve Memo to File or SOP/Protocol/Study Plan deviations;When applicable, 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 as to maintain timeline and scheduling commitmentsWhen applicable 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 backgroundsTo write, review and updated method SOP as neededParticipate in meetings with clients, conferences and scientific outreachConduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policiesRespecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work proceduresRequirementsUniversity or College degree in Chemistry, Biochemistry, Immunology or applicable field.At least 1-3 years of relevant ADA experience is a mustKnowledge 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)What We OfferWhy apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.About UsBrunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.