Scientist, Pk & Biomarker

About The Role

The Scientist, PK & Biomarkers is assigned to projects based on scientific competency and training. 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.

What You'll Do Here

• Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction.

• Assigned 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 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.

• When 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 approved 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 commitments.

• When 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 backgrounds.

• 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.

What You'll Need to Succeed

• 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 years of experience.

• Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations.

• Good organizational skill.

• Highly flexible.

• Sense of urgency.

• Excellent troubleshooting skills.

• Client oriented.

• Attentive to details.

• Ability to coach/mentor people.

• Good communication both written and verbal in French & English.

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the above language requirement. This requirement is essential for the position of Scientist , PK & Biomarkers in particular, but without limitation, for the following reason(s):

• The requirement to have study protocols read and documented in English as required by industry regulatory agencies

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

• Telework when applicable

Altasciences’ Incentive Programs Include

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Reviews

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