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Resume of HEE, Ph.D.
Consultant

EXPERTISE AND SERVICES

Pharmaceutical Scientist, Quality Control, Method and Process Development and Validation Consultant, Specialist, Forensic Analysis Investigation Expert, Patent Infringement, Expert Witness Testimony, Consulting Services
Expertise in protein purification, column chromatography, filtration, precipitation, centrifugation and freeze-drying, clinical testing activities, GMP/GLP analytical laboratory building and resourcing, documentation for quality policies, training, protocols, quality procedures and validation reports, protein, chemistry, spectroscopy and chromatographic assays.

This KKAI Associate offers expertise specific to quality control, manufacturing, and clinical studies assay methodologies, equipment / instrument validation studies and 21 CFR 11 compliance, method and process deviation investigations, new QC method and instrument introductions, setting specifications, 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, analytical method, process and instrument validation projects, and compliance issue defense during inspections by FDA and third party auditors, documentation for various US / International regulatory submissions and new product BLA license applications, FDA and International licensing of A1PI, IgG, albumin and coagulation products

PRINCIPAL INDUSTRIES SERVED
Biotechnology, Chemical, Medical, Pharmaceutical

EDUCATION
Ph.D. Chemistry, University of Southern California
MS/BA Chemistry, California State University Long Beach

Continuing Education:
Alpha Training courses on Management Skill Development and cGMPs. PDA meeting on Biotechnology Process Validation & Multiproduct Facility Issues. ACS course on Analytical Development and Validation. FDA meetings on analytical methods development and validation. Industry seminars on analytical, instrument/software and manufacturing validations. LAL methods for endotoxins. FDA Quality Systems Inspection Technique. FDA presentations on regulatory compliance. Thrombosis and Haemostasis/ Scientific Standardization Committee Meetings, American Society of Hematology meetings. FDA meeting on analytical methods characterization of biological products and assessment of comparability. AOAC/AAPS Analytical Meeting at FDA center, Irvine, CA. IBC meeting on Biological Assay Development and Validation

PROFESSIONAL EXPERIENCE
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.

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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.

HONORS AND AWARDS
Alpha achievement prize for Process Validation Project and Detection of impurities in plasma products
Alpha Chairman and President's Award for exemplary service and outstanding contribution

PROFESSIONAL AFFILIATIONS
ASQ
PDA
AOAC
ACS
AAPS

PUBLICATIONS
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-vWf stability studies of a reconstituted AHF product, FIXa international standardization studies, inactivation of Hepatitis A virus during the dry heat step in a high purity FVIII product, immunochemical and biochemical characterization of alphanate, alpha-1-acid glycoprotein purification process and product, clinical trial assessing intramuscular administration of immunoglobulin, quantitative detection of low levels of hepatitis a antibodies in healthy volunteers, determination of PEG in protein using an SPE technique, analytical biochemistry, inorganic chemistry, freeze-drying and moisture measurement of plasma derived proteins, and more.

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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