Scientifique senior, PK et biomarqueurs at Altasciences
Laval, QC, Canada -
Full Time


Start Date

Immediate

Expiry Date

30 Oct, 25

Salary

0.0

Posted On

30 Jul, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

English, Pk, Regulatory Agencies, Working Environment

Industry

Pharmaceuticals

Description

YOUR NEW COMPANY!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.

Responsibilities

ABOUT THE ROLE

We are seeking a Senior Scientist for our Ligand Binding Department (PK and Biomarker Unit) located in Laval. The Scientist will be responsible for the oversight of immunoassay 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.
For this position we are looking for Scientists that are experienced in conducting GLP large molecule drug quantitation for either non clinical TK or clinical PK studies. The candidate will have experience in sandwich/direct/competitive ELISA, ECLIA and/or Luminex assays. It is of added value if the candidate also has experience in developing multiplex assays for biomarkers on ECLIA and/or luminex. It is of added value if the candidate has experience in working with various tissue matrices or biopsies.

WHAT YOU’LL DO HERE

  • Could 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 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
  • 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;
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