pharmaceutical quality control, validation expert consultant
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Resume of HEE, Ph.D. Consultant
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  • Biotechnology
  • Chemical
  • Medical
  • Pharmaceutical

This consultant received a Doctorate Degree in Chemistry from the University of Southern California, a Master's Degree and a Bachelor's Degree in Chemistry from the California State University-Long Beach.

Pharmaceutical Quality Control, Validation Expert Consultant
 

This expert specializes in protein purification, column chromatography, filtration, precipitation, centrifugation, and freeze-drying. Additional areas of expertise include clinical testing activities, GMP/GLP analytical laboratory building and resourcing, and documentation for quality policies. Training, protocols, quality procedures and validation reports are related fields. Other fields of knowledge are protein, chemistry, spectroscopy and chromatographic assays.

This associate offers expertise specific to quality control, manufacturing, clinical studies assay methodologies, equipment / instrument validation studies, and 21 CFR 11 compliance. Other areas of specialization include method and process deviation investigations, new QC method and instrument introductions, setting specifications, and process and cleaning validation studies.

Additional experience and specialization includes methods transfer and regulatory compliance, OOS investigations and implementation of corrective actions, FDA and European regulatory audit participation, and analytical method. Process and instrument validation projects, compliance issue defense during inspections by FDA and third party auditors, documentation for various US / International regulatory submissions and new product BLA license applications are related fields. Other areas of expertise include FDA and International licensing of A1PI, IgG, albumin and coagulation products.

Consultant, Kevin Kennedy Associates Inc.

Providing project management, pharmaceutical science, quality control, method and process development and validation expertise consulting to clients in a wide variety of industries.

 

Associate Director, Analytical Development and Validation

Was responsible for QC methods development and validation, process validation, and clinical testing activities. Instrumental in building and resourcing of new GMP/GLP analytical laboratory. Set up documentation for quality policies, training, protocols, quality procedures and validation reports. Experienced in various protein, chemistry, spectroscopy and chromatographic assays. Developed, validated and improved assay methodologies for quality control, manufacturing, and clinical studies. Reviewed equipment/instrument validation studies and 21 CFR 11 compliance. Active team member in method and process deviation investigations, new QC method and instrument introductions, setting specifications, process and cleaning validation studies, methods transfer and regulatory compliance. Perform OOS investigations and implement corrective actions. Participated in audits by FDA and European regulators. Successfully defended analytical method, process and instrument validation projects, and compliance issues during inspections by FDA and third party auditors. Prepared documentation for various US/International regulatory submissions and new product BLA license applications. Worked towards FDA and International licensing of A1PI, IgG, albumin and coagulation products. Able to work successfully in a multinational environment with employees at company locations in Europe and Japan. Team player able to manage collaborative and multidisciplinary projects.

 

Manager Analytical Services, Alpha Therapeutic Corporation, Los Angeles, CA

Supervised R&D analytical studies, methods development and validation, manufacturing process validation, stability, and clinical release testing of new products. Set-up and validated assays to characterize and release products. Experience with analytical assays SDS-PAGE, Immunoblots, protein assays, GC, GC-MS, IC, SEC-HPLC, AA, and LAL. Collaborated with Alpha subsidiaries to transfer analytical and manufacturing process technology.

 

R&D Scientific Project Manager, Alpha Therapeutic Corporation, Los Angeles, CA

Developed and scaled-up plasma protein purification processes. Worked towards clinical manufacture and FDA licensing of plasma coagulation products. Implemented viral inactivation procedures in manufacturing. Developed human plasma protein products for use as gene therapy vectors. Experience with protein purification, column chromatography, filtration, precipitation, centrifugation and freeze-drying. Successful in transferring manufacturing processes to European subsidiary.

 

Research Associate, University of Southern California Medical School Biochemistry/Chemistry Departments

Isolated, purified and characterized proteins. Utilized fermentation, column chromatography and bioanalytical techniques.

This expert is a patent holder and author of numerous publications on topics related to viral inactivation, clinical studies, analytical method standardization studies, measurement of residual moisture in hygroscopic plasma-derived proteins, FVIII-v

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