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CGMP Clinical Chemist-Medical Device Product Development-R&D and Validation

Technical Consultant #2519


Expertise

Summary

  • Experienced Senior Scientist with a proven track record in research and product development/ support/ validation.
  • Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications.
  • Subject matter expert for chemistry and test method validation on behalf of clients’ companies.
  • Numerous processes validation during compliance updates and for new products and product improvement projects.
  • Managed teams of up to 20 engineers / chemists.  Revised risk analysis documents for all assemblies and subassemblies.
  • Validated over 100 chemistry assays for several automated chemistry analyzers. Evaluated each assay for 10+ test method parameters according to FDA approved standards. 
  • Conduct numerous internal and vendor audits.
  • Train and mentor associates in software, databases, bloodborne pathogens, FDA audit survival and proofreading.
  • Develop assays Expert to diagnose and monitor the following diseases / conditions:  Diabetes, cardiovascular disease, hemoglobinopathies, newborn screening (hypothyroidism, PKU, galactosemia, Biotinidase deficiency, cystic fibrosis – both IRT and DNA testing, MSUD, acylcarnitines and amino acids via tandem mass spec), electrolytes, enzymes, serum proteins and minerals / metabolites (Calcium, magnesium, uric acid, urea, creatinine).
  • Product improvements for sterile in vivo sensors used in heart lung machines. 
  • Assays developed based on chemical, fluorescence, time-resolved fluorescence, absorbance, immunoassays, DNA, monoclonal antibodies, random access clinical chemistry analyzers, mass spec, X-ray fluorescence and colloidal gold.

cGMP Clinical Chemist 

  • FDA approved 510(k)s (n = 133 products). 
  • Novel FDA 510(k) approvals (including the first de novo approval).
  • Invented first commercial Hemoglobin A1c kit.
  • cGMP, cGLP, ISO 9000 experience/trained. 
  • Process and test method validation.
  • Cleanroom Validation.
  • Project management. 
  • Test method development. 
  • Process development. 
  • cGMP, cGLP, FDA quality and compliance.
  • Technology development and site transfers. 
  • Developmental stability program management and setting expiration dating. 

Experience

Independent Consultant, 2020 - Present

  • Sole proprietor of scientific consulting company. Specializing in FDA registrations, GMP compliance, IVDs, process improvement and validation (equipment, process, test method and cleaning validation).

Terumo Cardiovascular Systems, Ann Arbor, MI, 2012 - 2020

  • Senior Engineer II. Duties include process improvement and validation of existing sensor chemistries for real-time monitoring during cardiac surgery.
  • Subject Matter Expert for Chemistry and Test Method Validation.
  • Processes validated during compliance updates and product improvement projects.
  • Managed teams of up to 20 engineers / chemists.
  • Validated the cleanroom manufacturing environment.
  • Validated five external and several internal test methods.
  • Established shelf-lives for all raw materials based on objective evidence.
  • Revised risk analysis documents for all assemblies and subassemblies in the business unit.

Alfa Wassermann, Inc., West Caldwell, NJ, 2005 - 2012

  • Senior Clinical Chemist and Director Reagent Sciences. Duties include validation and regulatory approvals of new chemistries and improvement of existing chemistries for a series of physician’s office/small laboratory autoanalyzers. Lead a team of seven scientists.
  • Validated over 80 chemistry assays for several automated chemistry analyzers. Evaluated each assay for 10+ test method parameters according to FDA approved standards.
  • Obtained 510(k) approvals for all analyzers and assays.
  • Led numerous process/product improvement projects.
  • Conducted internal and vendor audits.
  • Trained and mentored associates in software, databases, bloodborne pathogens, FDA audit survival and proofreading.

S.C.I. Inc., Consulting, Akron, OH, 2001 - 2005

  • Sole proprietor of scientific consulting company. Clients include PerkinElmer Life Sciences, Akron, OH – NCS Product Support and Development and Diamyd Medical AB, Stockholm, Sweden – Director of Technical Service and Director of R&D for Diamyd, Inc., Raleigh, NC.
  • PerkinElmer Life Sciences – Mapped production and quality control processes and implemented improvements, trained operations staff, handled/reviewed complaints and acquired customer specifications/performance data. Managed the stability program.
  • Diamyd, Inc – Set up GMP/product development system, conducted R&D and provided technical support.

Perkinelmer Life Sciences, (Isolab, Inc.), Akron, OH, 1976 - 2001

  • $220 million manufacturer of research and clinical screening products. A division of PerkinElmer, a $1.7 billion global technology company providing products to the pharmaceutical, chemical, semiconductor and photographic markets.

Director Assay Development, 1993 - 2001

  • As team leader of a group of up to eight scientists, I directed development of and provided evaluation data for six different newborn screening kits, based on a fluorescent microplate instrumentation platform. These kits generate millions in revenue annually.
  • Wrote specifications and evaluated software for instrument control and data reduction using mathematical optimization algorithms in Microsoft Excel with Microsoft Access database storage of results.
  • Developed other kits for screening newborn babies by tandem mass spectrometry.
  • Wrote protocols and managed clinical trials for the evaluation of these kits.
  • Provided evaluation data for FDA 510(k) applications – including the first de novo approval (no predicate device) of an in vitro diagnostic kit (Neonatal Biotinidase Assay) and the first newborn screening kit for cystic fibrosis.
  • Wrote SOPs for developing and evaluating new products using design controls.
  • Conducted internal audits.
  • Instituted a trouble-shooting method and used it to solve problems at customer sites and in manufacturing.
  • Trained associates, customers, and sales representative on newly developed products.
  • Developed and transferred manufacturing protocols and quality control methods to operations.
  • Project manager for several successful technology transfers (two international).

Manager Assay Development, 1984 - 1992

  • Developed kits for hemoglobinopathy testing (two-minute, non-instrument membrane capture assay).
  • Wrote SOPs for assay procedures, instrument usage, instrument maintenance, QA, quality control procedures, and product evaluations (stability, precision, interference, linearity and detection limit).
  • Developed kit for monitoring diabetic control and generated application notes for 6 clinical autoanalyzers.
  • Generated income of $100,000/year to Isolab from the licensing of a patent.

Manager Special Chemistry/R&D Lab Technician, 1976 - 1983

  • Responsible for assay development of special chemistry kits.
  • Developed four different kits for monitoring diabetic control (including the first commercial assay for HbA1c), testing fetal lung maturity and Tay-Sachs testing.
  • Developed disposable ion exchange/affinity chromatography kits for anemia and LDL cholesterol testing.

Honors & Publications


Academic and Professional Affiliations

  • American Chemical Society
  • American Association for Clinical Chemistry
  • National Academy of Clinical Biochemistry
  • International Society for Neonatal Screening
  • Biotinidase Deficiency Standardization Subcommittee
  • Galactosemia Standardization Subcommittee
  • Toastmasters International - Advanced Communicator Gold, Silver, and Bronze,    Competent Toastmaster Award
  • Several grants successfully executed

Publications and Patents 

  • Author of Articles (7), Posters (27)and Inventor of numerous Patents

Author and Co-Author of scientific papers and peer reviewed articles with subjects in: 

  • Diabetic monitoring and screening
  • Fetal Lung Maturity testing
  • Hemoglobinopathies
  • Interference testing
  • Stability testing
  • Monoclonal antibodies

Patents include the following assays: 

  • Hemoglobin A1c (first commercial test), fructosamine and glycated proteins
  • Agmatine immunoassay
  • Enzymatic assays for newborn screening and fetal lung maturity testing
  • Blood collection of filter paper

Education

  • Ph.D.  Chemistry (Biochemistry), The University of Akron, Akron, OH
  • M.S.   Chemistry, The University of Akron, Akron, OH
  • B.A.    Chemistry, Cum Laude; Case Western Reserve University, Cleveland, OH
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