Statistical Analysis and support of projects in Clinical Development Labs, Molecular Biomarkers Lab, Clinical Biomarkers and Pharmacology, Safety Assessment and Lab Animal Resources Projects across 3 sites (Rahway, NJ, Boston, MA and West Point, PA). Data Curation and analysis of Nanostring and Novel Aptamer Platform (SomaLogic) technologies. Was leading statistician in analyzing urine derived biomarker panel for Acute Kidney Injury (AKI) to replace an existing clinical candidate. Was leading statistician in analyzing comparative effectiveness of Core Needle Biopsy (CNB) vs Fine Needle Aspiration (FNA) samples through qPCR assays of a panel of genetic biomarkers. This also included blood derived biomarkers data to highlight effectiveness of FNA over CNB. Was leading statistician in analyzing High Content Screening(HCS) data in an exploratory toxicology study creating unique data panels to compare responses of multiple chemical entities in standardized cell based assay across multiple cell lines. Was a contributing co-author in exploratory studies in an effort to predict early onset of Alzheimer's Disease through plasma and CSF derived protein biomarker panel.

Statistical Analysis and support of projects in Clinical Development Labs, Molecular Biomarkers Lab, Clinical Biomarkers and Pharmacology, Safety Assessment and Lab Animal Resources Projects across 3 sites (Rahway, NJ, Boston, MA and West Point, PA). Data Curation and analysis of Nanostring and Novel Aptamer Platform technologies. Was leading statistician in analyzing urine derived biomarker panel for Acute Kidney Injury (AKI) to replace an existing clinical candidate

● Provided Project Plan/scheduling/delivery timelines (Microsoft Project).● Implemented Watson 7.2 LIMS for immunoassay services department.● Trained scientists, project managers, study managers,● Associate directors and operation manager on the use of LIMS for immunoassay. ● Trained Sample management lab personnel on the use of LIMS for sample login.● Reviewed and revised a major industry std Excel template on method validation.● Developed and authored SOPs for immunoassay in the● use of LIMS, Statistical Data analysis,● Immunoassay method development and validation. ● Revised and reviewed analytical plans for conduct of projects.● Interfaced with clients on progress of study● Review of results and delivery of final reports.● Served as point of contact for immunoassay instrument validation efforts.● Provided project financial forecasting in Excel.

● GLP Validation:Tecan Freedom Evo Workstation ● with Evoware and Magellan Clinical Software● GLP Validation: Softmax Enterprise version 4.31 and v 5.01● Application Administrator, Tecan Evoware, Softmax Pro Enterprise 4.31,● Softma Pro v 5.01, StatLIA● GLP Validation:Facility wide migration/upgrade of Microsoft OS/Office Products● GLP Validation:StatLIA software and LIMS for Ligand Binding Assays● Extensive experience:use of Softmax Pro 4.31 in Immunoassays● Antibody Drug Conjugates(ADC), Immunogenicity, PK, Ab analysis ● Trained 30 scientists, PIs, Study Managers, Assoc Dirs, Operations Managers● Cut Point analysis, Statistical Analysis of large data sets● Key point of Contact/Data Liaison Manager for Global Vaccine trials● Key point of Contact for Global Multi-Site Trials for 10+ studies of 30,000 patient samples● Sample Management Databases upload and verification● GLP LIMS validation● Led cross-functional team of 15 in effective use of LIMS for immunoasays● Prepared weekly minutes of Method Dev Group meetings● Updated Project Schedules/timelines for completed, ongoing and new projects● Trained Scientists, Principal Investigators, Study Managers and Lab Personnel● On the use of Softmax Pro, StatLIA, Nautilus LIMS, Statistical Data Analysis● Prepared project plans and forecasts for proposals to new clients/projects● Interfaced with clients via site visits, teleconferences and facility audits● Provided guidance to Metrology issues with Lab instruments● Certifications in: → GLP Training → Softmax Pro Enterprise, StatLIA, Tecan System Administrator training → 21 CFR Part 11 Compliance for Electronic record keeping → Six Sigma Principles and Team Member Training → Lean Sigma Principles → Finance 101 → Japanese Culture and orientation → Signature Client Service → eQA system for Quality Assurance → EHS & Radiation Safety Training

● Implementation Team: Roche-Zeiss collaboration on ● Multi-module, Multi-modal automated screening system● Innovative design and demonstration of Fluorescence Polarization detection mode● On a unique Zeiss 96 mini-lens array whole plate detection imaging platform● Hands-on Bench level experience on Radio-Ligand, Fluorescence,● Flurescence Polarization, ELISA, Bio and Chemi Luminescence Assays● RNase, Casein Protein Degradation Fluorescence Polarization assays, ● Tomtec, Tecan, Beckman-FX platforms for liquid handling● Perkin Elmer, Wallac-Victor V, Envision, Spectrafluor Plus● MicroBeta, Packard Top Count HTS, detection systems● Project Manager: Mitshubishi articulated robotic arm integration with● Tecan-TRAC Genesis platforms and TeMo liquid handling systems● With Velocity-11 microplate centrifuge and Viewlux whole plate imaging platforms● Evaluation of Engineering Arts picoliter dispensing module● Evaluation of Perkin Elmer, Molecular Devices non contact● Reagent / Cell Dispensing for 96 / 384 / 1536 well microplates→ EHS & Radiation Safety Training → Tecan Liquid Handling / FACS training→ Wallac ViewLux / Victor V/Envision/MicroBeta Training→ CyBio Liquid Handling training→ Carl Zeiss Service Training

Implemented the first company wide 384 well screen in a High throughput screening campaign of CMV protease target against a 200,000 member diversified collection of small molecule libraries. The project involved setting up a 384 new and innovative liquid handling platform, new 384 well microplate reader, validating miniaturized fluorescent enzymatic kinetic assay in 384 well plates and developing a Excel based data acquistion, reduction scheme for uploading of data to corporate database. Member of novel target discovery team of the infectious diseases group, attended weekly meetings, arranged for third party vendors to present their technologies, new instrumentation and integrated robotic platforms. Developed the first innovative 1536 well indexing arrangement on a TomTec 384 well pipettor using two solenoid actuators as a demonstration concept with the help of Biomedical Engineering Dept,

High throughput screening support of Zymark systems, microplate readers for enzymatic, kinetic, radio ligand, time resolved flourescence assays. Projects for identifying small molecules against novel antibacterial, antiinfective, oncologic and metabolic targets. Settng up robots for natural products extraction, compound management, biomedical engineering department interfacing for inhouse projects

Founding member of Bioengineering Department at Startup. Joint patent holder,in delivery and distribution of combinatorial chemical libraries to 96 well microplates. Quality control of polymeric solid supports for combichem library synthesis. Initated implementation and testing of in-house whole plate imaging platform used in lawn format biological assays. Evaluated laser micro-machined glass wafers for high density format enzymatic and cell based assays using the proprietary combichem libraries

● Center for Manufacturing Research● Department of Mechanical Engineering● Research, Teaching, Service, Committees, Supervision● Professional Societies● ASME, SME, MRS, APS, Am Ceramic Soc

● Center for Manufacturing Research● Department of Mechanical Engineering● Research, Teaching, Service, Committees, Supervision● Professional Societies● ASME, SME, MRS, APS, Am Ceramic Soc

Manufacturing Engineering Sciences, Statistics, Design of Experiments, Box-Behnken reduced 3 factorial experimental design, Tool Geometry Optimization, Roadmap for process improvement

Manufacturing Processes, Materials, Tribology