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Resume of BYT, Ph.D.
Consultant

EXPERTISE AND SERVICES

Biochemist, cGMP, GLP, GCP, Quality Assurance, Quality Control Consultant, Regulatory Compliance and Validation Consultant, Forensic Analysis Investigation Expert Witness Testimony, Consulting Services
Expertise in FDA regulations, cGMP, GLP's, GCP's, management of methods development, quality assurance and regulatory compliance, validation, new product licensing and market introduction.

Specialization includes quality control of all aspects of pharmaceuticals (solid dosage forms and parenteral), vaccines, clinical diagnostic products, product submissions, IND, NDA, PLA, ANDA, management, communication, team interaction, problem resolution, network computer system implementation in laboratory settings, contract manufacturer and contract lab audits, internal QA processes, and product releases.

This KKAI consultant offers expertise specific to environmental monitoring, water systems, development of QA Systems, SOP's, specs, calibration programs, GMP and safety training, audit policies, QA Systems, SOP's, SPEC's, lab supervision, biochemistry, immunology, chemistry, microbiology, and virology.

Additional experience includes recombinant products QC, testing method development and validation, product stability database development and implementation, automated high volume testing, QA/QC of diagnostic & biological products, LIMS systems, development of new methods, testing and release of new products for clinical trials, cancer research, and diagnostic products

PRINCIPAL INDUSTRIES SERVED
Biochemistry, Biomedical, Biotechnology, Environmental, Pharmaceutical, Water Systems

EDUCATION
Post Doctoral Fellowship, University of Minnesota
Ph.D., Biochemistry, Kansas State University

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing project management, cGMP, GLPs, GCPs, quality assurance, quality control consulting, regulatory compliance and validation expertise and consulting to clients in a wide variety of industries.

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Biochemist, cGMP, GLPs, GCPs, Quality Assurance, Regulatory Compliance and Validation Consultant

Provided consulting pertaining to cGMP Compliance and Regulatory Affairs for clients including a peptides and polycolonal antibody services firm, Affymax Corporation, Agensys Corporation, Alliance Pharmaceuticals, American Peptide Company, Inc., Bayer Pharmaceuticals, Genentech Corporation, NORAC Corporation, and Novartis-Chiron.

Vice President, Quality Assurance & Regulatory Affairs, American Peptide Company, Inc., Sunnyvale, CA

Was responsible for quality systems, validation, internal audits, documentation, contract manufacturer and contract lab audits, internal QA processes, product releases, environmental monitoring, water systems, development of QA Systems, SOP’s, specs, calibration programs, GMP and safety training, audit policies (Vendors & Contract Labs). Prepared Drug Master Files (DMF), CMC, IND Supplements.

Director, Quality Assurance & Regulatory Compliance, Alpha 1 Biomedicals, Inc., Sunnyvale, CA

Responsibilities included all QA activities (documentation, product releases, validation, internal audits, contract manufacturer and contract lab audits, internal QA processes) and Quality Control laboratory functions. Developed QA Systems, SOP’s, SPEC’s, Calibration program, GMP training, Audit policy (Internal, Contract Vendors and Labs).

Manager, Quality Control, Baxter Healthcare Corp, Hayward, CA

Responsibilities included supervision of all lab support functions, including biochemistry, immunology, chemistry, microbiology, and virology & QC of all recombinant products in Hyland Division's Biotech facility. Updated Environmental and WFI monitoring systems. Established turn-around times for testing functions.

Associate Director, Quality Control and Analytical Development, Collagen Corporation, Palo Alto, CA

Responsibilities included supervision of all lab functions, Chem and Micro, QC of all products, development and validation of testing methods. Constructed, equipped and validated new Sterility testing facility. Developed and implemented product stability database system. Validated five final product test methods.

Manager, Biological Testing and Development, Biological Division, Lederle Laboratories [Wyeth Pharma], Pearl River, NY

Responsibilities included QC of commercial and clinical products (vaccines and therapeutics), development of biological testing methods, set-up of first departmental computer network. Automated high volume testing by using a robot (Zymark). Successfully managed expansion of laboratory facilities due to increased staff, while maintaining a full workload schedule.

Product Line Manager, Diagnostic Quality Control, Hoffman-La Roche, Inc., Nutley, NJ

Responsibilities included QA/QC of diagnostic & biological products. Effectively managed reduced headcount of 70% by restructuring assignments and elimination of least critical testing functions. Implemented a LIMS system. Extended the shelf life of finished products by 20%.

Manager, Analytical Research, Hoffman-La Roche, Inc., Nutley, NJ

Responsibilities included development of new methods, testing and release of new products for clinical trials, coordination of QC commitments for new product submissions (IND, NDA, PLA, 510K, PMA). Staffed and equipped the first biological and diagnostic products analytical development department. Directed methods development for various diagnostic products. Developed methods and prepared appropriate CMC sections for the first Biotechnology product Interferon for an IND submission.

Group Leader, Analytical Research, Hoffman-La Roche, Inc., Nutley, NJ

ADDITIONAL EXPERIENCE

Senior Scientist, Analytical Research, Hoffman-La Roche, Inc., Nutley, NJ

Associate Biochemist, Sloan-Kettering Cancer Center, New York City, NY
Performed basic cancer research.

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Case Studies

Biochemist, cGMP, GLP, GCP, Quality Assurance, Quality Control Consultant, Regulatory Compliance and Validation Consultant, Forensic Analysis Investigation Expert Witness Testimony, Consulting Services
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