1. George A. Baklayan
7455 Paloma Drive
Huntington Beach, CA 92648
(714) 847-5604 (home)
(714) 717-9894 (cell)
email georgebaklayan44@gmail.com
EDUCATION
• University of Southern California
M. S. Pharmaceutical Sciences, G. P. A. 3.53
• University of California, Los Angeles
B. S. Psychobiology
RESEARCH EXPERIENCE
George Baklayan 1/15 – present
Pharmaceutical Development Consultant
• Experience with a history of success involving diverse aspects of the
pharmaceutical and biotechnology industry including: analytical method
development and validation, process development, non-clinical pK and safety
studies, research and development, and regulatory filings.
• Proven leader of departments and project teams in the successful development of
products from conception to launch.
• Experienced in managing department and project budgets, including costing and
forecasting.
ISTA Pharmaceuticals/Bausch and Lomb Pharmaceuticals/Valeant
Pharmaceuticals, Irvine, CA 2/01 – 9/14
Director, Pharmaceutical Development
• Developed and launched 6 products, making ISTA one of the fastest growing
companies in Orange County
• Inventor on multiple patents and first author on multiple publications
• Started and organized a group to handle all process and analytical development,
formulation development, stability, pre-clinical testing, process and method
validation and transfer.
• Manufactured and tested GLP supplies for animal testing.
• Responsible for all animal GLP studies performed by outside laboratories
• Worked on CMC and pre-clinical sections of NDA’s and IND’s for multiple
products. Gained approval for multiple NDA’s.
• Set drug product specifications for release and stability. Wrote justifications for
specifications based on available data and negotiated specifications with FDA.
• Worked with outside CMO’s for technology transfer of methods and processes.
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2. • Supported manufacturing facility in Wales, England by reviewing all documents
(SOP’s, IQ/OQ/PQ protocols, master batch records, process development and
validation protocols). Helped write process validation protocol and master batch
records. Aided in successful transfer of process to both New Zealand and United
States.
• Conducted numerous virus validation studies at Bioreliance, Rockville, MD on
various steps in the purification process. Conducted studies to evaluate the use of
different virus removal filters in the purification process. Trained manufacturing
personnel on the use and integrity testing of the virus filters and conducted virus
validation studies on the filters.
• Conducted process development studies examining multiple variables (e.g.
protein load, flow rates, pH, etc.) on all steps in the hyaluronidase purification
process. Conducted column packing and lifetime studies. Implemented changes
in MBR’s to insure adequate controls prior to pre-validation and process
validation. Developed sampling plan for pre-validation and validation.
• Developed assays to quantitate products, degradants and impurities. Assays
included an SDS-PAGE stability indicating assay, affinity HPLC, ELISA,
spectrophotometric, and quantitative SDS-PAGE assays.
• Wrote method and process development reports. Wrote method validation
protocols and final validation reports. Helped QC in the validation of methods.
• Trained and supervised personnel.
• Conducted studies for photostability of drug substance and drug product as well
as the removal of process related impurities.
• Participated in successful Pre-Approval Inspections (PAI).
Xoma Ltd., Santa Monica, CA. 8/92 – 2/01
Manager, Pharmaceutical Development
• Started and organized a central analytical biochemistry group to provide all
necessary assay support to Quality Control, technical development, pilot plant
operations, fermentation, and research groups in Santa Monica. Set up and
maintained HPLC systems and existing methods. Provided assay support in the
form of HPLC (ion exchange, reverse phase, size exclusion, affinity, tryptic map,
amino acid analysis), ELISA, SDS-PAGE, spectrometry, western blots, LAL, etc.
Assays run under cGMP guidelines and aided in product release for phase I, II,
and III clinical testing.
• Developed new tests and improved existing tests to monitor and quantitate
natural and recombinant proteins, contaminants, excipients, and breakdown
products. Assays developed included reverse phase, ion-exchange, affinity, and
size exclusion HPLC using both UV and RI detectors, SDS-PAGE, protein
activity, ELISA, spectrophotometric, and a novel IEF procedure for basic
proteins.
• Trained and supervised personnel in analytical assays.
• Validated and transferred new methods to Quality Control. Methods included
HPLC, DNA threshold, protein activity, ELISA, and SDS-PAGE.
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3. • Purified and identified contaminants and breakdown products. Methods to
identify contaminants and breakdown products included protein sequencing, mass
spectrometry, ELISA, western blots, and HPLC.
• Conducted stability studies on formulations of products and stability of in-process
pools and resins used in the purification of products. Formulation stability studies
were conducted on both liquid and lyophilized products. Long term studies at
normal and elevated temperature looked for mechanisms of breakdown and/or
precipitation.
• Assisted in cGMP and research purification of products.
• Set up HPLC systems to do pre-column derivatization and analysis of fermentor
samples for amino acid content as well as surfactant analysis of final product
samples.
• Wrote and conducted process validation protocols and final results. Validation
included the removal of viruses, DNA, and protein contaminants during product
purification. Independently conducted viral clearance studies at both Tektagen,
Inc., Malvern, PA and Bioreliance, Rockville, MD.
• Prepared written technical development reports, SOP’s, and test methods.
University of Southern California, Los Angeles, CA 8/89 – 8/92
Research Associate
• Research on the mechanism of action of chemotherapeutic agents. Work included
the study of the changes in a number of nuclear proteins induced by selective anti-
cancer drugs in human tumor cell lines. Techniques included polyacrylamide gel
electrophoresis of proteins, cell culture, HPLC, spectrometry, protein extractions
and assays, immunoblotting. Independent planning of one’s work and
experiments emphasized. Course work and thesis applied towards M.S. degree.
California Institute of Technology, Pasadena, CA 9/87 – 7/89
Research Associate
• Research and development in the area of protein chemistry. Work included low
picomole sequencing of proteins as well as high resolution two-dimensional gel
electrophoresis, silver staining and electrotransfer of proteins for immunoblotting.
• Computer analysis of protein sequences as well as computer searches of protein
databanks conducted. Proficient in the use of many types of HPLC used in both
sequencing and digestion/mapping of proteins.
REFERENCES
Will be furnished upon request.
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