Senior Scientist II

The Senior Scientist is assigned to projects based on scientific competency and training. The
Scientist will ensure the overall integrity/quality of assigned studies. The Senior Scientist can
also be designated as the main contact for client interactions laboratory for their assigned
projects and have Direct Reports.

Job Requirements:

Tasks Performed:
• 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;
• Other related tasks.