Sheree Buckingham Email & Phone Number

Raleigh-Durham, North Carolina Area

Durham, Nc

Responsible for developing, validating, and troubleshooting, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies according to GLP guidelines•Perform qualification, validation, transfer, sample analysis, and ADC assays•Analyze and interpret data using Gen5 and Watson LIMS•Author and review plans and reports for validation and sample analysis•Design assay runs, worksheets, plate maps, summary tables, and data tables per client DTA•Order laboratory supplies and maintain inventory on project supplies, reagents, and critical reagents •Manage sample receipt and testing for specific clients•Communicate timelines and data to clients•Formulation of buffers, assay controls, and antibody conjugations•Serve as system owner of the Rees monitoring system•Assist in the management and scheduling of bioanalytical projects•Serve on the equipment alarm response team using Accsense and Rees monitoring systems

Raleigh-Durham, North Carolina Area

Responsible for developing, validating, and troubleshooting, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies according to GLP guidelines•Perform qualification, validation, transfer and sample analysis assays•Analyze and interpret data using Gen5 and Watson LIMS•Author and review plans and reports for validation and sample analysis•Design assay runs, worksheets, and plate maps •Set up studies in Watson LIMS•Order laboratory supplies and maintain inventory on project supplies and reagents •Prepare summary and data tables for qualification, validation, and sample analysis•Manage sample receipt and testing for specific clients•Communicate timelines and data to clients•Formulation of buffers, assay controls, and antibody conjugations•Perform ADC assays following proper safety requirements

Raleigh-Durham, North Carolina Area

Responsible for developing and validating biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies

Research Triangle Park, Nc

Associate Scientist responsible for organizing, leading, and performing assay control, working reference standard, and antibody qualifications for drug substance and drug product release assays.•Authored reagent qualification protocols, qualifications reports, and SOPs•Formulation of reagents, controls, antibody conjugations, and perform antibody titrations•Authored Annual Method Reviews for validated test methods•Perform assay validation testing and method transfer •Statistical analysis on qualification data using LabWare LIMS, NWA, JMP, and MS Excel•Project Management and cross-site qualification scheduling•Perform method troubleshooting and optimization•Technical investigation writing for invalid assays and deviations assessing method, material, environment, equipment, personnel.•Managed trending of controls to ensure method performance

Research Triangle Park, Nc

Associate II – Quality Control – Bioanalytical January 2013 - January 2014Quality Control Associate responsible for performing environmental monitoring, routine testing, and activities associated with executing this testing in a cGMP manner. Provide testing support for drug substance and drug product, transfer qualification and validation, assay control, robust and compliant cGMP documentation and technical support. •Performed release and stability testing for biological potency and impurity in the QC Bioassay Laboratory•Execute cell based cytopathic effects assay, cell proliferation assay, ELISA and Immunoassay on MSD and EnVision platforms•Reconstitution and preparation of release and stability samples for testing•Performed titration and confirmation assays for method reagents•Review of assay results for release•Cell culture of adherent cell lines using aseptic technique

Research Triangle Park, Nc

Associate ScientistAssociate Scientist within a technical/ analytical development department responsible for supporting drug development and manufacturing by executing analytical testing of pharmaceutical products and intermediates. •Analyzed protein solutions with modern analytical methodologies•Qualified and formulated reagents to be used in analytic testing of drug substances•Carried out immunological assays including qPCR, ELISA, ECL, DELFIA, FRET, and measurement of protein concentrations•Analyzed data using Softmax Pro, PLA 2.0, Microsoft Excel•Fulfilled necessary requirements for GMP documentation including laboratory notebooks, assay forms, and storage of data into NuGenesis Unify

Created humanized models for research of drugs causing drug induced liver injury. Developedprotocols, study guidelines, IACUC statements, experiment management and pilot studies. Performed end point analyses including tissue removal, sectioning, staining, fixing, and preliminary pathological evaluation. Accountable for data acquisition via ELISA, plate assays, flow cytometry, miRNA, and real time PCR.• Assisted necropsy techniques, fixation procedures, and gross trimming of tissue. • Performed routine, special stains, immunohistochemistry, and BrdU staining for cell proliferation.• Performed micro dissection techniques on reproduction and urogential systems. • Entered necropsy testing data via the computer and maintained the histopathology testing program records. • Assisted in hematology by preparing blood samples/bone marrow smears for hematology parameters.

A working scientist, within cGMP/cGLP environments, accountable for the sample and fluid management of a new blood chemistry analyzer project. Provided daily, weekly, and monthly FDA regulated quality control, documentation, and maintenance of medical devices. Formulated and prepared calibrators, controls, reagents, and samples for verification and validation of new software, and newly manufactured blood chemistry analyzers. • Created SOPs and customer directions for the use of materials, and for the utilization of products in a hospital setting. • Managed budgets, purchase orders, and materials for multiple projects, and was responsible for the documentation and final reports for FDA approval and release.• Assisted in the development of new clinical assays: early cardiac markers, cancer markers, and infectious disease tests. Clinical assay development involved screening for cross reactive samples, assay interferents, and formulation of synthetic analytes.• FDA/ISO regulated quality documentation management • Management of QC/QA/QS aspect of clinical projects • DTS managing, record keeping and data retrieval• Performed Validation and verification of in vitros diagnostic products for release to the market.• Patient sample handling, processing, and repository management • Infectious disease processing, manipulation and management • Synthetic analyte preparation, assay evaluation, and compound preparation• Formulation of reagents, controls, and calibrators for FDA regulated medical device manufacturing • Database management and maintenance, data analysis (MS Access/Excel/GraphPad prism/Provantis)• Budgeting and purchase order management for verification and validation projects

Churchville, Ny

Induced anesthesia, assisting with surgical procedures, monitoring surgery patients, and administering medications and vaccines. Managed controlled substances, and completed all documentation regulated by the FDA.

Canangaigua, Ny

Assisted the veterinarian with routine and emergency farm animal calls

Rochester, New York Area

Trained on inventory management, filling prescriptions, and advocate drug information

Bachelor'S Degree, Biology/Biological Sciences, General

Associate'S Degree, Veterinary/Animal Health Technology/Technician And Veterinary Assistant