Michael E. Barnett, M.S., Ph.D.

Cell 785-***-****

acvpf0@r.postjobfree.com

Skills Summary: Relevant expertise in the regulated Food and Drug sector. Experience in design, efficiency, separations, solubility, solvent chemistry, air/water/product handling, clean room/formulation hygiene, root cause analysis, implementation of 6Sigma processing approaches, validation of systems, operations, and analytical assays. Experience in the implementation and maintenance of cGMP systems as well as working in a GLP setting. I have experience in the interpretation and implementation of 21CFR210-211. I have a diverse analytical skill set based on mass spec (ESI), HPLC, GC, UV, IR, and Fluorescence with regard to raw material characterization, in process monitoring/conformance, final substances/products, understanding yield and partitioning coefficients, as well as how design hierarchy is related to costs and design space. With regard to physical biochemistry, I have experience with primary sequences, secondary structural elements, tertiary arrangement, and quaternary structure including post translational modifications. I have experience with clarity, color, solubility, moisture, density, viscosity, TOC (ppt), and microbiological counts including endotoxins. I have worked with protein ligands, fatty acids, polymers, and many types of molecules. I understand how to characterize particle sizes, mechanics of light scattering, and how physical properties of substances affect dissolution (porosity, tortuosity, solubility, particle size, pH, solvent chemistry, and other factors). I know how to try to solve solubility, partitioning, and other types of issues through effective experimental design and testing. I have developed ELISA assays, generated high quality antibodies with high titer, purified high quality antibodies, and implemented protease and endotoxin assays in 96 well format.

EXPERIENCE

FilmatEleven 8/2015 – Present

Current Sales Associate

Participate in the tinting of glass and many other services for various purposes

Involved in day to day operations of a business with a diverse product profile

Trained in various skills and tasks utilizing diverse systems and equipment

Interact with customers and sell upgrades at the $1000.00 to $10,000.00 level

Manage resources and personnel to execute services in a friendly, timely, and efficient manner

Carry out processes as directed by SOP

Ventria Bioscience 6/2007 – 9/2014

Director of Process Chemistry

Developed, designed, and directed the implementation of critical corrective actions which allowed for the successful production of four or more products. Designed and scaled up processes which produce products under cGMP standards, developed necessary PAT technology, developed and validated analytical methods and cleaning procedures

Carried out major root cause analysis based on 6Sigma statistics collected under my management

Developed, tested, and implemented corrective actions and set criteria for future manufacturing

Directed the separations chemistry for development of a greater than 99% pure protein pharmaceutical excipient that meets strict limits for endotoxin, host cell proteins and dna, bound plant phenols, and degradation fragments

Developed and validated cleaning protocols and testing methods using model substances, stainless steel, plastic, and glass with TOC and microbiological assays

Played a key role in the conversion of a cell culture product process from ISO9001 standards to cGMP standards with regard to compliance with 21CFR210-211

In one instance, my engineering ability led directly to the conversion of 10% passage of specifications to more than 90% passage of specifications making a major product line viable

Specifically reduced endotoxin levels from 5-10 EU/mg protein substance to 0.005 EU/mg of protein and conducted tests using the gel clot method, turbidimetric, rFC, and chromogenic methods using the maximum valid dilution (MVD)

Assisted in reducing inability to recover spikes due to protein binding and became familiar with causes of interference in common endotoxin testing

Solved major impurity issues for a phase II clinical substances by properly engineering the equipment in terms of throughput vs. capacity, operational parameters, and impurity profiling using ESI-MS and HPLC

Operations Engineer/Process Scientist

Supported the day to day production of recombinant proteins from host expression systems; involved in the entire process from bench scale investigation to final scale up and release of product

Lead the development of re-engineered and new units of operation, pilot testing, and implementation of new technologies

Responsible for characterization, equivalency findings, as well as development and validation of QA/QC methodology for product certificates of analysis

Developed and validated many analytical methods including two penultimate methods that are used to determine degree of milling, and product criteria testing

Worked extensively with solvents needed to carry out particular separations, developed methodology based on solvent/solubility knowledge and experience successfully

Set up and executed 3-5 year stability studies based on quantification of degradation products using various HPLC methods and ESI MS

Discovered conditions that would decrease degradation and modification rates

Department of Biochemistry, Kansas State University 07/1999 – 06/2007

Research Associate 01/2004-6/2007

Lead a project that constructed, delivered, and tested pharmaceutical delivery vehicles (HSA, PEG, antibodies, modified proteins and lipids) in cell culture, mice, and gene knock-out mice

Utilized testing including HPLC, 2D electrophoresis, and endotoxin testing to clear materials for injection

Successfully produced recombinant PKC isozymes from bacteria and cell culture as well as Immunoglobulins from hybridoma cell lines

Special attention to product attribute testing, as well as contaminant/impurity profiling including endotoxins, Lipids by GC, proteins by RP HPLC, and general ESI MS

Research Assistant 12/2002-1/2004

Expressed, isolated, and purified recombinant proteins using modern DoE approaches to find best conditions given both yield and purity for cross-optimization

Characterization utilizing MS, DSC, ITC, UV-VIS-IR Spectroscopy, NMR, CD, and Fluorescence

Focused on protein/protein interactions and protein/ligand interactions as they relate to thermodynamics, statistical mechanics, and solvent based chemical equilibria and irreversible processes

Extensive work developing novel HPLC assays that successfully detected valid molecular interactions which were both novel and difficult to detect by conventional methods

Practiced separations strategies with regard to ultra-filtration and chromatography

Laboratory Manager and Research Assistant 07/1999-12/2002

Summary: Validated analytical assays used by multiple users, wrote standardized SOPs for both production of products as well as analytical assays to characterize products. Learned to write validation plans for process unit operations as well as analytical assays. Paid careful attention to application of statistics to biological assays and the necessary details needed to determine the level of validity given a specific test with regard to Limit of detection and quantification (based on both signal to noise ratio and general standard deviations), precision, accuracy, intermediate precision, linearity, range, recovery, and robustness. Became proficient at sample preparation with regard to spike recovery, false negative, and false positive results. Assisted in the management of PhD and MS projects with regard to training, physical resources, and personnel. Carried out preparatory and analytical methods. Studied yield and purity conformance over statistically significant numbers of processes.

PUBLICATIONS (Journal Articles)

1.Synergistic cooperation between two ClpB isoforms reveals the rate limiting step in aggregation reactivation. Nagy, M., Guenther, I., Akoev, V., Barnett, M., Zavodszky, M., Kedzierska-Mieszkowska, S. JBC. In press.

2.Protein Kinase C Epsilon activates lens Mitochondrial cytochrome C oxidase subunit IV during hypoxia. Barnett, M., Lin.D., Akoev, A., Willard, L., Takemoto, T. Exp. Eye Res. 2008, 86(2), 226-234.

3.Protein Kinase C as a Stress Sensor (Review Article). Barnett, M, Madgwick, D., Takemoto, D. Cell Signaling 2007, 19(9), 1820-1829.

4.Human Serum Albumin Nanoparticles for efficient delivery of Cu, Zn superoxide dismutase gene. Yun, M., Barnett, M., Raghava, S., Takemoto, D., and Kompella, U. Mol. Vis. 2007, 13, 746-757.

5.PKCγ Knockout Mouse Lenses are More Susceptible to Oxidative Stress Damage. Lin, D., Barnett, M., Lobell, S., Madgwick, M., Zampighi, G., and Takemoto, D. J. of Exp. Biology, 2006, 209, 4371-4378.

6.Expression of Superoxide Dismutase in Whole Lens Prevents Cataract Formation. Lin, D., Barnett, M., Grauer, L., Robben, J., Jewell, A., Takemoto, L., and Takemoto, D. Molecular Vision, 2005, 11, 853-858.

7.The N-terminal Domain of ClpB Enhances Chaperone Function. Chow, I., Barnett, M., Zolkiewski, M. Baneyx, F. Federation of European Biochemical Societies Letters, 2005, 579, 4242-4248.

8.The Amino-terminal Domain of ClpB Supports Binding to Strongly Aggregated Proteins. Barnett, M., Nagy, M., Kedzierska, S., and Zolkiewski, M. Journal of Biological Chemistry, 2005, 349**-*****.

9.Nucleotide-induced Switch in Oligomerization of the AAA+ ATPase ClpB. Akoev, V., Gogol, E., Barnett, M., and Zolkiewski, M. Protein Science, 2003, 13, 567-574.

10.Structure and Function of the Middle Domain of ClpB. Kedzierska, S., Akoev, V., Barnett, M. and Zolkiewski, M. Biochemistry, 2003, 42(48), 142**-*****.

11.Site-directed Mutagenesis of Conserved Charged Amino Acid Residues in ClpB. Barnett, M. and Zolkiewski, M. Biochemistry, 2002, 41(37), 112**-*****.

12.Structure and Function of the Amino-Terminal Domain of ClpB. Barnett, M., Zolkiewska, A. and Zolkiewski, M. Journal of Biological Chemistry, 2000, 275(48), 375**-*****.

(Of Significant Nature- Project Reports)

1. Removal of bound lipopolysaccharide (LPS) from human serum albumin in industrial scale process streams.

2. cGMP compliant, economical, fully scalable purification system for recombinant human serum albumin which meets or exceeds the USP reference standard for purity and quality.

3. Stabilization of recombinant human serum albumin liquid products by orthogonal protease removal mechanisms.

4. A penultimate RP-HPLC test to measure the purity/impurities of Human Serum Albumin as well as measure the amount processing contaminant, residual Triton X-114.

5. Full 21-CFR210-211 validation of a protease assay for the testing and comparison of protein products.

6. A chemo-metric system based on UV-VIS spectrophotometry developed and validated for plant protein product streams that can measure protein, dna, and plant phenols simultaneously and allows for the monitoring of mass and yield conformance in-process.

7. Removal of the 2% w/w fats that are bound to recombinant human serum albumin.

8. A model that allows for rapid identification of the correct chemical space to explore for chromatography development based on characterization of the impurity proteins (host cell and degradation products.

9. Statistically significant changes in mass spec data during a 4 year stability study of a drug substance in phase II clinical trials.

PATENTS

1. Aseptic Extraction of Rice Endosperm Proteins in the absence of Starch.

2. Hsp70 family proteins increase productivity of Cell Culture Media Bioreactors.

EDUCATION

Doctor of Philosophy (Ph.D.) Biochemistry

Graduate Biochemistry Group, College of Arts and Sciences, Kansas State University 12/2004

Master of Science (M.S.) Biochemistry

Graduate Biochemistry Group, College of Arts and Sciences, Kansas State University 11/2001

Bachelor of Science (B.S.) Biochemistry

Department of Biochemistry, College of Arts and Sciences, Kansas State University 05/1999

PhD Thesis: Time Stands Still, Physical Biochemistry Characterization of the Molecular Interactions of ClpB and Model Aggregated Substrates (with Examination of Equilibrium Binding and Energetics of Interactions).

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