Designed and executed pharmacokinetic (PK) and immunogenicity (ADA) immunoassays independently, based on protocols provided by literature, seminars and other scientists. Troubleshoot assay-related problems.Summarized and presented results to supervisor and senior management.Wrote assay validation protocols for review by Study Director prior to submission to Quality Auditing (QA).Communicated with QA to schedule critical phase audits for validation studies and prepared draft audit responses.Expertly performed validation exercises, summarized results in a tabular manner. Wrote validation reports and SOPs for review by the Study Director.Performed Long Term Stability (LTS) studies for validated methods. Updated SOPs to incorporate LTS data.Independently trained on validated ELISA methods and performed sample analysis.Trained other Assay Development Associates on area of technical expertise. Served as a role model and mentor within the group.Communicated with other groups within the company and outside vendors to obtain assay-related reagents or discuss reagents needs.Evaluated new technologies for the development of immunoassays using new formats or techniques.Maintained GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs. Assisted in maintaining GLP compliance in the laboratory.Complied with safety requirements of the laboratory. Recognized potential safety problems and took action to correct them.Managed direct reports.

Design, develop and execute pharmacokinetic immunoassays and perform validation exercises. Troubleshoot assay-related problems.Generate assay validation protocols for review by Study Director.Liaise with Quality Auditing to schedule critical phase audits for validation studies and prepare draft audit responses.Perform Long Term Stability (LTS) studies for validated methods and update SOPs to incorporate LTS data.

Successfully optimized and validated ex vivo stimulation and ELISA assays.Validated whole blood flow cytometric assays for phenotypic profiling of various cell populations. Transferred assays to contract laboratories for GLP-like validation and clinical sample analysis, including on-site training and troubleshooting.Validated assays according to GLP standards on the innovative Singulex platform for the analysis of clinical samples.Monitored assay validation activities of external contract laboratories. Trained contract laboratories personnel on transferred assays.Trained co-workers in area of expertise. Performed data analysis and interpreted results from assay validation and feasibility studies.Proposed, executed and optimized assay feasibility studies, assay development, and sample measurement on various immunoassay platforms in support of therapeutic areas and translational area biomarker programs.Authored technical reports, analytical method and Standard Operating Procedures (SOPs) to detail and document internal data for projects in support of the biomarker groups, in accordance with GCP, GLP and company policy.

Developed a novel bead-based approach for isolating antibody/antigen complexes in human plasma for verification of a kinetic characterization model. Designed and interpreted experiments aimed to validate immunoassays from various technology platforms (i.e. ELISA, MSD) for transfer to external laboratories in support of clinical trials.Generated analytical method description and reports for validated immunoassays.Functioned as a Point of Contact (POC) for laboratory management and safety.Complied with applicable regulations, include maintaining record of studies in accordance with GLP guidelines.Trained and supervised junior scientists.

Performed epitope mapping assays on Streptococcus pneumoniae strains for the vaccine Prevnar 13TM. Completed cell surface expression analysis of LP2086 and CapB proteins on numerous strain variants of Neisseria meningitides in support of vaccine clinical trials against the serogroup B meningococcal disease.Generated validation reports and SOPs for ELISPOT and flow cytometric assays for implemention in clinical trials.Participated in the Cancer Vaccine Consortium ELISPOT panel.Responsible for clinical trial supply management for phase one studies. Maintained user inventory database of biological specimens/reagents. Acted as a POC for instrumentation calibration, management and preventive maintenance.Responsible for IQ/OQ/PQ and validation of equipment to comply with GLP and company policy.Trained co-workers in area of expertise.

Independently designed and executed experiments for dendritic cell pulsing of tumor-specific antigens.Collaborated with laboratory investigators in formulating experimental design and assisted with data collection on multiple projectsCollected and processed clinical samples in compliance with GCP standardsComposed grant sections and abstracts for submission

Implemented experimental procedures as indicated by the principal investigatorAssisted in experimental designAided principal investigator in administrative duties Managed and instructed medical and Westinghouse Science Talent Search students in laboratory protocols and techniquesPOC for laboratory maintenance and safetyPerformed data entry and analysis