LC-MS Method Development Scientist

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 Youll 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 Youll 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.

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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