• Principal Investigator for developing and troubleshooting an immunofluorescence assay for clinical trial phase II testing for bacterial vaccines. Generated supporting documentation including addendums, amendments, memos, protocols, deviation and reports in support of assay execution.• Completed equipment and data investigations when necessary to ensure the accuracy and dependability of the data produced.

• Redeveloped multiple ELISA based assay in support of vaccine clinical testing. • Lead a team of nine colleagues in support of instrument organization, maintenance, calibration, documentation, training and investigation. Performed process improvements and updated SOPs. • Principal Investigator for developing and troubleshooting an immunofluorescence assay for clinical trial phase II testing for bacterial vaccines.• Completed equipment and data investigations when necessary to ensure the accuracy and dependability of the data produced.• High throughput clinical testing using a cell based assay in phase III and IV for bacterial vaccine. Resulted in expansion of age range for FDA approved product usage.• Designed and conducted research and development experiments for cell based assay. Resulted in the successful validation of a new bacterial serotype for clinical testing.• Developed and performed troubleshooting for ELISA assays for clinical trial phase II for viral vaccines. Resulted in the successful qualifications of the assays for clinical testing.• Performed and reviewed documentations in accordance with SOPs, GLP, internal guidelines and additional sponsor requirements. Resulted in no internal audit findings through QA.• Trained and qualified on various cell based assay across multiple sites of the company to provide support and expertise.• Pipette team leader responsible for the organization, maintenance, calibration, documentation, and pipette investigation of 900 pipettes. Assisted in redesigning an efficient routine calibration process across the department and established an updated protocol for remedial maintenance. • Performed non-clinical PI duties that included communicating with the clients as well as other PI’s and various other internal teams. Ensured all stages of testing and review completed efficiently and within an appropriate timeframe which provided accurate results to the client in a timely manner.

• High throughput clinical testing using a cell based assay in phase III and IV for bacterial vaccine. Resulted in expansion of age range for FDA approved product usage.• Performed and reviewed documentations in accordance with SOPs, GLP, internal guidelines and additional sponsor requirements. Resulted in no internal audit findings through QA.• Trained and qualified on two cell based assay across multiple sites of the company to provide support and expertise.• Pipette team member and assisted with the calibration of approximately 700 pipettes. Also assisted in completing remedial maintenance on appropriate instruments.• Performed tracking and trending of the Streptococcus pneumonia serotypes.