Senior Scientist, PK & Biomarker

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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.

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;

What You’ll Need to Succeed

• Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field.

• Experience in developing immunological methods, ideally ELISA/ECLIA.

• Knowledge of regulatory agency guidelines; must deeply understand general SOPs and have an excellent knowledge of GCP/GLP regulations.

• Preferred experience in regulated clinical and/or preclinical studies with typically 3 years of experience.

• Minimum of 2 years experience as Scientist II or equivalent.

• Good organizational skill, highly flexible, sense of urgency, excellent troubleshooting skills,

• Able to easily read and understand study plans and protocols and ability to coach/mentor people.

• Client oriented, attentive to details.

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

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Senior Scientist, PK & Biomarker including, but not limited to, for the following reasons:

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!