Job Description

Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Primary Responsibilities
The Senior Research Scientist is assigned to projects based on scientific competency and training. The Senior Research Scientist will ensure the overall integrity/quality of assigned studies. The Senior Research Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects.
Tasks Performed

• Could be assigned to assay development, qualification, validation and production expert in multiple assay types and mentor for more junior staff.
• Will be contribute to scientific outreach through posters and/or presentations. Mentor for junior staff.
• 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 rom 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;
• Other related tasks.

Qualifications

• 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. Minimal 2 years experience as Scientist II or equivalent.
• Knowledge of regulatory agency guidelines, must deeply understand general SOPs and have excellent knowledge of GCP/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.

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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!