Experience

Oakton College

• United States
• Higher Education
• 500 - 600 Employee

• Adjunct Faculty

  • Jan 1994 - Present

  Taught General Biology with emphasis on biochemistry for undergraduate students. Taught General Biology with emphasis on biochemistry for undergraduate students.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Principal Technical Support Scientist

  • Apr 1998 - Jan 2012

  * Subject matter expert for cardiac and anticonvulsant drug products. * Provided technical expertise for user needs document (UND)/product requirement document (PRD), specification setting, dFMEA (design failure mode and effects analysis), trace document, design plan, manufacturing and testing documents, risk Assessment, investigation, test method conversion, and validation. * Led AxSYM Digoxin III improvement project per design control policy, which included design and development plan:… Show more * Subject matter expert for cardiac and anticonvulsant drug products. * Provided technical expertise for user needs document (UND)/product requirement document (PRD), specification setting, dFMEA (design failure mode and effects analysis), trace document, design plan, manufacturing and testing documents, risk Assessment, investigation, test method conversion, and validation. * Led AxSYM Digoxin III improvement project per design control policy, which included design and development plan: design input, design verification, design validation and pre-market tasks. * Led a cross-functional team for assay launch: quality, marketing, operation, regulatory, medical affairs, labeling, assay system integration, quality engineering, validation, and planning. * Provided technical and scientific leadership to improve and maintain in vitro diagnostic product availability and implemented improvement/resolutions related to in-process manufacturing, analytical testing, qualification of rare reagents, documentations, assay standardization, and risk management. * Provided technical and scientific leadership for expanded investigation, identified root causes or causative agents and implemented corrective actions related to nonconformance, internal failure investigation, manufacturing process improvement, test method validation, and field performance problems. * Applied quality policy in areas of design control (change control and CAPA closures), material controls (qualification of rare reagents), production and process controls (specification setting, verification and validation), and document control (device master record). * Used design of experiment (DOE) for projects associated with expanded investigation, process improvement and test method, and statistical tools to develop verification and validation protocols. Show less * Subject matter expert for cardiac and anticonvulsant drug products. * Provided technical expertise for user needs document (UND)/product requirement document (PRD), specification setting, dFMEA (design failure mode and effects analysis), trace document, design plan, manufacturing and testing documents, risk Assessment, investigation, test method conversion, and validation. * Led AxSYM Digoxin III improvement project per design control policy, which included design and development plan:… Show more * Subject matter expert for cardiac and anticonvulsant drug products. * Provided technical expertise for user needs document (UND)/product requirement document (PRD), specification setting, dFMEA (design failure mode and effects analysis), trace document, design plan, manufacturing and testing documents, risk Assessment, investigation, test method conversion, and validation. * Led AxSYM Digoxin III improvement project per design control policy, which included design and development plan: design input, design verification, design validation and pre-market tasks. * Led a cross-functional team for assay launch: quality, marketing, operation, regulatory, medical affairs, labeling, assay system integration, quality engineering, validation, and planning. * Provided technical and scientific leadership to improve and maintain in vitro diagnostic product availability and implemented improvement/resolutions related to in-process manufacturing, analytical testing, qualification of rare reagents, documentations, assay standardization, and risk management. * Provided technical and scientific leadership for expanded investigation, identified root causes or causative agents and implemented corrective actions related to nonconformance, internal failure investigation, manufacturing process improvement, test method validation, and field performance problems. * Applied quality policy in areas of design control (change control and CAPA closures), material controls (qualification of rare reagents), production and process controls (specification setting, verification and validation), and document control (device master record). * Used design of experiment (DOE) for projects associated with expanded investigation, process improvement and test method, and statistical tools to develop verification and validation protocols. Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Technical Support Scientist

  • 1996 - 1998

  * Provided technical and scientific leadership for CK-MB assay: manufacturing issues, assay improvement, troubleshootings, and field performance problems. Improved purification process of CK-MB conjugate polyclonal antibody. * Supported the product maintenance of AxSYM TROPONIN I and provided technical support for Troponin I discrepant sample investigation project and conjugate improvement. * Supported customer relations (both internal and external) such as complaint investigation… Show more * Provided technical and scientific leadership for CK-MB assay: manufacturing issues, assay improvement, troubleshootings, and field performance problems. Improved purification process of CK-MB conjugate polyclonal antibody. * Supported the product maintenance of AxSYM TROPONIN I and provided technical support for Troponin I discrepant sample investigation project and conjugate improvement. * Supported customer relations (both internal and external) such as complaint investigation, conference call with customer, literature information, and implementation of assay performance data tracking.

• Clinical Chemistry:Technical Product Development Group Leader

  • Nov 1994 - Apr 1996

  * Managed clinical chemistry multiconstituent calibrators value verification, troubleshooting, value assignment and verification process improvements, test method validation, and shelf life dating extension study. * Provided technical support for all clinical chemistry reagents with respect to scientific data, change request, material review report, etc in order to achieve maximum product availability and maintain minimum inventory. * Characterized clinical chemistry reagents (20… Show more * Managed clinical chemistry multiconstituent calibrators value verification, troubleshooting, value assignment and verification process improvements, test method validation, and shelf life dating extension study. * Provided technical support for all clinical chemistry reagents with respect to scientific data, change request, material review report, etc in order to achieve maximum product availability and maintain minimum inventory. * Characterized clinical chemistry reagents (20 reagents) such as reagent optimization, heat stability, reaction progress curve, absorption spectrum, various sample to reagent ratios, linearity, and comparison with other commercially available reagents.



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Alzheimer's Disease (AD) Diagnostics, Project Leader

  • 1987 - 1994

  * Identified, established or/and implemented collaborations with Abbott-funded and non-funded external research collaborators in U.S., Europe, and Japan (19 institutions): collaborations encompass screening of cDNA library, cloning, expression of gene, isolation and characterization of Neural Thread Protein (NTP) and Alzheimer's Disease Associated Proteins (ADAP), development of antibody, immunocytochemistry, expression of Alzheimer's related proteins in cultured olfactory neuroblast cells… Show more * Identified, established or/and implemented collaborations with Abbott-funded and non-funded external research collaborators in U.S., Europe, and Japan (19 institutions): collaborations encompass screening of cDNA library, cloning, expression of gene, isolation and characterization of Neural Thread Protein (NTP) and Alzheimer's Disease Associated Proteins (ADAP), development of antibody, immunocytochemistry, expression of Alzheimer's related proteins in cultured olfactory neuroblast cells, neuropathology, sample acquisition, and research clinicals. * Led Neural Thread Protein (NTP), Alzheimer's Disease Associated Proteins (ADAP) and other AD marker projects that include IMx immunoassay development, protein biochemistry, immunochemistry, molecular biology, and research clinical study. Supervised 2 Ph.D. scientists, 2 exempts, and 2 technicians at NIMH. * Project leader of AD biological marker research funded by National Institute on Aging (NIA) AD Drug Discovery Grant. Isolated and studied substrate specificity of cathepsin D using amyloid synthetic peptides. Investigating AD specific immunoreactivity to explore the development of in vitro model (SHSY 5Y, human neuroblastoma) * Investigated NTP biochemistry (Isolation, characterization, amino acid sequencing), immunochemistry, and molecular biology. Developed Pancreatic Thread Protein (PTP) IMx enzyme immunoassay and completed evaluation of NTP in clinical specimens such as cerebrospinal fluid. * Supervised protein biochemistry lab for Alzheimer's project. Isolation, characterization, amino acid sequence, immunochemical properties and cDNA library screening of Alzheimer's Disease Associated Proteins. Investigated amyloid precursor protein as a potential AD diagnostic marker in cerebrospinal fluid.

• Research Biochemist

  • 1984 - 1987

  * Developed enzyme purification procedures, characterized, stabilized, and studied enzyme kinetics (malate dehydrogenase, ascorbic oxidase, hexokinase, glycerol kinase, glucose 6-phosphate dehydrogenase). * Formulated clinical chemistry reagents using enzymes purified by Abbott for China Project, compared with commercially available enzymes and completed in-house clinical evaluation. * Researched, formulated, developed , and marketed C-reactive protein (CRP) and formulated Bilirubin… Show more * Developed enzyme purification procedures, characterized, stabilized, and studied enzyme kinetics (malate dehydrogenase, ascorbic oxidase, hexokinase, glycerol kinase, glucose 6-phosphate dehydrogenase). * Formulated clinical chemistry reagents using enzymes purified by Abbott for China Project, compared with commercially available enzymes and completed in-house clinical evaluation. * Researched, formulated, developed , and marketed C-reactive protein (CRP) and formulated Bilirubin reagents.



Harvard University

• United States
• Higher Education
• 700 & Above Employee

• POSTDOCTORAL, Department of Nutrition, Harvard School of Public Health

  • 1981 - 1984

  * Investigated dietary fat saturation on plasma lipoprotein and high density lipoprotein metabolism of the Rhesus monkey by determining lipid composition, esterified fatty acids, apolipoprotein concentration and distribution, physical characteristics of lipoprotein particles, and kinetics of AI and AII metabolism. * Produced, characterized antibodies, and developed immunoassay for quantification of apolipoproteins. * Investigated dietary fat saturation on plasma lipoprotein and high density lipoprotein metabolism of the Rhesus monkey by determining lipid composition, esterified fatty acids, apolipoprotein concentration and distribution, physical characteristics of lipoprotein particles, and kinetics of AI and AII metabolism. * Produced, characterized antibodies, and developed immunoassay for quantification of apolipoproteins.