Scientist, ADA Immunogenicity

CareAbout•Laval, QC

1d•Onsite

About The Position

We are seeking a Scientist for our Ligand Binding Department (immunogenicity Unit) located in Laval. The Scientist will be responsible for the oversight of immunogenicity study conduct from assay development and optimization based on study requirement, to validation and sample analysis. The Scientist will be the primary contact to the client for all scientific discussions pertaining to all study phases. The Scientist will review all data generated and communicates results to clients in regular meetings and writes final reports.

Requirements

College degree and/or University degree in Biochemistry, Immunology or applicable field.
must understand general SOPs.
Good organizational skill, highly flexible, sense of urgency
Excellent troubleshooting skills
Client oriented
Ability to coach/mentor people
Good communication both written and verbal in French & English

Nice To Haves

Preferred experience in developing immunological methods, ideally ELISA/ECLIA.
Experience in regulated clinical and/or preclinical studies is a plus

Responsibilities

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
Support and mentor analysts, troubleshoot and resolves issues with methods under their responsibility or technical issues in the laboratory when scientific expertise is needed
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
May be required to review and provide comments and recommendations, as needed to the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed
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
Respect Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures