Associate Scientist, ADA

CareAbout•Laval, QC

About The Position

The Associate Scientist, ADA is the right hand help for the senior scientist. As such their responsibility is mainly to assist the senior scientist with tasks based on scientific competency and training. Based on competencies the Associate Scientist may be assigned as BPI.

Requirements

Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field.
Preferred experience in regulated clinical and/or preclinical studies with typically 3 year of experience.
Knowledge of regulatory agency guidelines and must understand general SOPs and have good knowledge of GLP regulations.
Good organizational skill.
Highly flexible, Sense of urgency.
Excellent troubleshooting skills, Client oriented, Attentive to details, Be able to easily read and understand study plans and protocols, Ability to coach/mentor people, Good communication both written and verbal in French & English.
The requirement to have study protocols read and documented in English as required by industry regulatory agencies

Responsibilities

Tabulate and perform final data batch review by performing multi-batch trend analysis, completing all study documentation as required including approving of Memo to File or SOP/Protocol/Study Plan deviations where appropriate.
Provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate.
Assist in writing validation and analytical plans/reports and provide comments and/or recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document.
Assist for planning sample analysis by maintaining timeline and scheduling commitments.
If assigned, perform the ordering of reagents, materials and if assigned verification of inventory.
Perform literature searches and draft work plans for the development of assays as assigned.
Assist with evaluation of risk and costing.
Based on training and competency, perform laboratory bench work for method development or validation, interpretation of results, documentation/tabulation of data and troubleshooting when required.
Keeps BPI and/or Senior Scientist involved through ongoing communications.
Write, review and update method SOP as needed
Support responses to QA reports
Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
Provide feedback on progress and assist in sponsor teleconferences as required.
Conduct all work in compliance with applicable SOPs, GCPs, GLPs and observes all company guidelines and policies.
Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures.