Catherine Pawlak Email & Phone Number | Diagnostics: Design and development of qualitative and quantitative medical diagnostic devices for point of care, clinical laboratory and reasearch markets. Development of new multiplexed biomarker immunoassays for prognosis of cardiovascular disease (CVD) utilizing Luminex technology platform. Evaluation of performance and validation of commercial proteomic panels for diagnostics and prognostics of CVD. Assessment of new diagnostic and proteomic technologies, custom assay development and OEM opportunities. Reagent formulation and drying in microfluidic applications of fluorocytometry. Management of immunoassay and product development: device design, component selection, system integration, process optimization, scale-up; clinical studies, 510k applications and technology transfer to manufacturing. Biochemistry: Academic research on biochemical and cellular mechanisms of action and selectivity of anticancer and antiviral agents. Management: Good managerial, organizational and teaching skills; able to focus and finish tasks in an efficient and timely manner and manage timelines of large projects. Familiar with intellectual property law, patent writing and interpreting. Practice of GMP, Design Control Requirements and FMEA (regulations, procedures, and documentation pertinent to R&D and Operations). Techniques: Hands-on knowledge of experimental methods and procedures in the areas of medical diagnostics, immunochemistry, biochemistry, anticancer and antiviral research, pharmacology, analytical and physical chemistry. Specialties: Immunochemistry, Biochemistry, Analytical and Physical Chemistry Assay and Process Design, Development, Optimization and System Integration Reagent and Materials Selection, Stabilization and Deposition Protein Purification and Modification Clinical Studies and 510K Applications GMP, Design Control Requirements, FMEA (procedures and documentation) Project Management

Catherine Pawlak

Diagnostics: Design and development of qualitative and quantitative medical diagnostic devices for p...
San Jose, California, United States

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Catherine Pawlak’s Email catherine.pawlak@bd.com

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Catherine Pawlak’s Location San Jose, California, United States

Catherine Pawlak’s Current Industry Bd Biosciences

Catherine Pawlak’s Prior Industry Aviir | Quidel | Metrika | Biogenex

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Work Experience

Bangladesh

Senior Scientist/Engineer

Present

Bd Biosciences

Senior Scientist/Engineer

2008-11-01 00:00:00 - Present

Aviir

Scientist

2007-11-01 00:00:00 - 2008-10-01 00:00:00

Quidel

R&D Project Manager

2000-02-01 00:00:00 - 2007-10-01 00:00:00

Metrika

R&D Director

1997-07-01 00:00:00 - 1999-08-01 00:00:00

Biogenex

Research Scientist

1986-06-01 00:00:00 - 1987-09-01 00:00:00

Skills

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FAQ About Catherine Pawlak

Catherine Pawlak is located at
San Jose, California, United States

Catherine Pawlak is a Diagnostics: Design and development of qualitative and quantitative medical diagnostic devices for point of care, clinical laboratory and reasearch markets. Development of new multiplexed biomarker immunoassays for prognosis of cardiovascular disease (CVD) utilizing Luminex technology platform. Evaluation of performance and validation of commercial proteomic panels for diagnostics and prognostics of CVD. Assessment of new diagnostic and proteomic technologies, custom assay development and OEM opportunities. Reagent formulation and drying in microfluidic applications of fluorocytometry. Management of immunoassay and product development: device design, component selection, system integration, process optimization, scale-up; clinical studies, 510k applications and technology transfer to manufacturing. Biochemistry: Academic research on biochemical and cellular mechanisms of action and selectivity of anticancer and antiviral agents. Management: Good managerial, organizational and teaching skills; able to focus and finish tasks in an efficient and timely manner and manage timelines of large projects. Familiar with intellectual property law, patent writing and interpreting. Practice of GMP, Design Control Requirements and FMEA (regulations, procedures, and documentation pertinent to R&D and Operations). Techniques: Hands-on knowledge of experimental methods and procedures in the areas of medical diagnostics, immunochemistry, biochemistry, anticancer and antiviral research, pharmacology, analytical and physical chemistry. Specialties: Immunochemistry, Biochemistry, Analytical and Physical Chemistry Assay and Process Design, Development, Optimization and System Integration Reagent and Materials Selection, Stabilization and Deposition Protein Purification and Modification Clinical Studies and 510K Applications GMP, Design Control Requirements, FMEA (procedures and documentation) Project Management