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Senior Scientist

2 months ago

Greater Montreal Metropolitan Area, Canada Brunel Full time

Senior Scientist – LBA (Flow Cytometry)

Montreal, QC


Introduction

The Senior Scientist is assigned to projects based on scientific competency and training. 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 in 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 Flow Cytometry
  • 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)



What We Offer

Why 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 Us

Brunel 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.