About The Role
The Scientist, LCMS 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
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.
Preferred experience in regulated clinical and/or preclinical studies with typically 3 years of experience.
Minimal 1 year experience as Scientist or equivalent.
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.
Be able to easily read and understand study plans and protocols and ability to coach/mentor people.
Good communication both written and verbal in French & English.
Must deeply understand general SOPs and have an excellent knowledge of GCP/GLP regulations.
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 Review
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Skills Required
- College or university degree in Chemistry, Biochemistry, Immunology, or a related field
- At least 1 year of experience as a Scientist or equivalent
- Typically 3 years of experience in regulated clinical or preclinical studies
- Knowledge of regulatory agency guidelines
- Excellent knowledge of GLP regulations
- Excellent knowledge of GCP regulations
- Understanding of general SOPs
- Excellent troubleshooting skills
- Ability to read and understand study plans and protocols
- Ability to coach and mentor people
- Good written and verbal communication skills in French and English
- Good organizational skills and flexibility
- Attention to detail and client orientation
What We Do
Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
