PK/ADA Scientist

About the role

The PK/ADA Scientist II 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.

Responsibilities

• 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)
• Manage project and order appropriate material, as needed
• Provide QC support on studies assigned to other team members in laboratory based on training and competencies
• 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
• Write, review and updated method SOP 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
• Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies
• Respect Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures

Requirements

• College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field
• Minimum 3 years of experience in a pre clinical/CRO
• 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

Qualifications

• Not specified

Skills

• Not specified

Benefits

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 Plans401(k)/RRSP with Employer MatchPaid Vacation and HolidaysPaid Sick and Bereavement LeaveEmployee Assistance & Telehealth Programs

Pay

Not specified

Schedule

Not specified