Senior Scientist

Company: Carrie Rikon & Associates, LLC.
Location: Columbia
Posted on: May 28, 2023

Job Description:

The Senior Scientist is assigned to projects based on scientific competency and training. TheScientist will ensure the overall integrity/quality of assigned studies. The Senior Scientist canalso be designated as the main contact for client interactions laboratory for their assignedprojects and have Direct Reports.Tasks Performed:--- Could be assigned to assay development, qualification, validation and production expert inmultiple assay types and mentor for more junior staff. Could have associate scientists and/orscientist I and II reporting to themAutonomous and proficient developing, planning, managing, conducting, reporting andtroubleshooting multiple assay types to ensure scientific quality, regulatory expectations, andclient satisfactionAssigned 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 PrincipalInvestigator and is the first point of contact for PM and/or clients for laboratory services andwill manage and conduct method development, qualification , validation and productionstudies 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 inlaboratory based on training and competencies.When applicable, perform data batch review, perform multi-batch trend analysis, completedocumentation as required by tracking deviations, events and reports of non-compliance andreview or approved Memo to File or SOP/Protocol/Study Plan deviations;When applicable, provide a report and/or reporting of results, within study timelines andensure any deviations/exception events are reflected as appropriate and assure that allanalysis 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 thebioanalytical 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 analysisand/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 themindependently via development of appropriate procedure.--- Organize and communicate complex data sets in a clear and concise manner to keystakeholders 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 observeall company guidelines and policies--- Respecting Health and Safety standards in terms of personal protection, laboratorymaintenance, and work procedures;--- Other related tasks.Powered by JazzHR

Keywords: Carrie Rikon & Associates, LLC., Columbia , Senior Scientist, Other , Columbia, South Carolina