Randall Bishop, Ph.D.

Senior Research Scientist
Eigenvector Research, Inc.

300 Evergreen View Drive
Holly Springs, NC 27540
phone: (919)946-2118
fax: (509)662-9214
e-mail: bishop@eigenvector.com

Education:

Ph.D. Chemistry, University of Georgia, 1997. B.S. Chemistry, East Tennessee State University, 1993.

Technical/Research Skills:

Experienced research and development chemist with ability to provide timely, data-driven solutions to process and product development issues.  GE Six Sigma Green Belt certification in statistical methods (DOE, Robust Design, process capability assessment, CQA identification).  Ability to find optimum solutions to the complex interactions between chemistry and process requirements. History of value-added innovations developed to practical fruition and business benefit.

Analytical Chemistry:  Extensive analytical chemistry experience and expertise -- Raman, midIR, NearIR, UVvis, pXRD, HPLC, IC, SEC, GC, LC-MS, DSC, TGA, optical microscopy, NMR, time-domain NMR, SEM/EDX, XRF.  Qualitative/Quantitative Chemometric Techniques (PCA, PLS, MCR, etc).


GE Six Sigma / Experimental Design Methodologies: Design of Experiments (DOE), DMAIC, Robust Design, Process Capability assessment, CQA identification, Measurement system analysis, Process Modeling.


Drug Development: Solid State Characterization for Drug Product and Process Development, Polymorph Screening, Salt Screening, Process Design Space Experimentation.


Computer Skills: Microsoft Office Suite, Statistical Analysis packages (JMP, Design Expert, Minitab), Matlab, Visio (process modeling), Multivariate/Chemometric packages (PLS_Toolbox, Solo,, Unscrambler), Thermo software, Agilent ChemStation, Perkin Elmer and Symyx Lab Automation products.

Experience:

Pfizer (formerly Wyeth Vaccines) – Research Triangle Park, NC 2009 to February 2010
Chemist, Biopharmaceutical Analytical Development

Supported Analytical Development efforts to develop, qualify, and validate analytical methods necessary for vaccine development, production, and release.  Provided laboratory instrumentation and data analysis expertise.  Defined and evaluated statistical experimental designs to assist in method development, optimization, and robustness studies. 

  • Championed the use of Statistical Experimental Design in the development of analytical methodologies.
  • Led the automation of Lowry Protein Assay resulting in an order of magnitude improvement in method precision.
  • Provided key gel electrophoresis evidence for solving a Phase III batch release issue for Clinical Trial Material;  E. Coli contamination from production process.

GlaxoSmithKline – Research Triangle Park, NC 2004 to 2008
Investigator, Chemical Process Development

Represented and resolved solid form drug developability issues that impacted bioavailability, chemical, and/or physical properties as member of drug development project team.  Experimentally defined the developable crystalline salt form and the most suitable crystal form (polymorph) via systematic screening strategies for progression into preclinical safety studies, human trials, and commercial formulations.  Supervised the screening activities of 2 scientific staff members, ensuring accuracy and integrity.  Served as department representative on Global Quality Team.

  • Investigated more than 50 drug compounds to determine best solid state form while accommodating timelines for candidate selection and first time in human (FTIH) key drug development milestones.
  • Led development of novel mathematical tools, software, and data analysis protocol for a new drug screening function in laboratory (e.g., salt and polymorph).  Facilitated achievement of the target number of 8 drug screens / year with a 60% cost avoidance verses an external vendor screen.
  • Increased lab productivity and information accuracy 20% by switching from distributed drug screening to single staff ownership.  Improved consistency and communication with internal customers.
  • Recruited to lead investigations of 2 problematic drug compounds.  Delivered developable results for both drugs and valuable knowledge space to drug product teams for successful progression into FTIH studies within defined project timelines.

GE Plastics – Mt. Vernon, IN 1997 to 2004
Analytical Chemist (1999 to 2004)

Supported analytical chemistry needs for all site functions, including raw materials production, primary and secondary polymer manufacturing, product development, and customer issue resolution. Served as Global Spectroscopy group leader to develop value-added, business-wide spectroscopy projects.

  • Achieved $900,000 in productivity savings by applying Near-Infrared measurement technology to Phenol production processes and quality assurance (QA) labs which also resulted in 2 process analytical (PAT) patents.
  • Led global standardization effort of spectroscopic instrumentation (midIR) and control software across 10 sites — led to 90% faster and simplified transfer of methods.
  • Delivered $100,000 in productivity savings in QA labs by developing application of Near-Infrared technology in Polybutylene Terephthalate (PBT) polymer manufacturing process.
  • Developed and delivered a successful Statistical Analysis / Design of Experiments (DOE) 2-day short course at professional conferences using GE Six Sigma methodologies.  Averaged 10 participants per session.

GE Technical Leadership Program (1997 to 1999)

Recruited into and completed 2-year leadership development program which provided participants with exposure to multiple aspects of business. Developed a strong foundation in identifying and leveraging internal intellectual assets and capabilities to address business issues.   

  • Developed novel on-line extruder-based midIR measurement for polymer composition.  Allowed for more precise compositional control of new polymer blend products during development.
  • Led competitive technology assessment teams, performed prior art search, and participated in internal patent portfolio evaluations.

Environmental Protection Agency – Athens, GA 1997
EPA Intern Program

Developed Raman measurement of tautomeric and zwitterionic microspecies

Publications:

Bezemer, E., Bishop, R., Gemperline, P., “Fully automated analysis for polymorph classification in high-throughput crystal form screening”, submitted 2008/ reviewed/ under revision - Analytical Chemistry.

Russian Patent (No. 2002113195),  Bishop, R.T., Fulmer, J., Zinenkov, A.V., Dyckman, A.S., "Automated Measurement of Alkylaromatic Hydroperoxides in Process Streams".

US Patent (US Application No. 2003/0213911 A1),  Bishop, R.T., Fulmer, J., Zinenkov, A.V., Dyckman, A.S., “Automated Measurement of Hydroperoxides in Process Streams”

Venkateshwaran, T.G., Stewart, J.T., Bishop, R.T., de Haseth, J.A., Bartlett, M.G. "Solution Conformation of Model Peptides with the use of Particle Beam LC/FT IR Spectrometry and Electrospray Mass Spectrometry",  J Pharm Biomed Anal, 1998, 17, 57 67.

Bishop, R.T., Turula, V.E., Ricker, R.D., de Haseth, J.A., "Hyphenated HPLC Methodology for the Resolution and Elucidation of Peptides from Proteolytic Digests", Techniques in Protein Chemistry, Vol. VIII. Academic Press, NY, 1997.

Turula. V.T., Bishop, R.T., Ricker, R.D., de Haseth, J.A., "Complete Structural Elucidation of a Globular Protein by Particle Beam LC/FT-IR Spectrometry and Electrospray LC/MS: Sequence and Conformation of β-Lactoglobulin", J Chrom, 1997, 763, 91-103.

Bishop, R.T., de Haseth, J. A., "Conformational Effects of Reversed-Phase HPLC on Ribonulcease A and α-Chymotrypsin by Particle Beam LC/FT-IR Spectrometry", Mikrochimica  Acta (Vienna), 14, 721-724, 1997.

Bishop, R.T., Turula, V.E., de Haseth, J. A., "Conformation Effects on Reversed Phase Chromatography of Proteins with Particle Beam LC/FT-IR Spectrometry and Free Solution Capillary Electrophoresis", Anal Chem, 1996, 68, 4004-4014.

Selected Presentations and Manuscripts:

Randall Bishop, Oral Session Organizer and Presider, FACSS 2006, “Pharmaceutical Raman: Process and Screening Applications”.

Randall Bishop, “Pharmaceutical Salt and Form Screening:  Challenges in High-Throughput Data Analysis.”, Symyx Software User’s Group Forum, June 2006. (Invited Speaker)

David Edwards, Randall Bishop, “The Utilization of Process Analysis, via Near-Infrared (NIR) Technology, in a Two-Step Chemical Reaction Process”, 18th International Forum on Process Analytical Chemistry (IFPAC), Arlington, VA, 2004

Randall T. Bishop, “Near Infrared at GE Advanced Materials“, ThermoElectron Research Symposium,  Seattle, WA and  Philadelphia, PA, 2004. (Invited Speaker) 

Randall T. Bishop, Mark Kemper, “Application of Near Infrared Spectrometry in Phenol Production: Multivariate Model Transfer of Spectrometer Based Transmission and Fiber Optic Immersion Probe Models", PITTCON, Orlando, Fl, 2003.

Short Course:  "Attack The Variance: Statistical Design Strategies for Analytical Method Development", Elizabeth Jordan, Randy Bishop, Ft. Lauderdale, Fl, 2003. and Providence, RI, 2002

Alexander Seyfarth, Randall T. Bishop, J.T. Henderson, , “Applications of XRF in the Plastics Industry”.  52nd Annual Denver X-Ray Conference, Denver, CO, 2003 (Invited Paper)

Randall T. Bishop, T.G. Venkateshwaran, James A. de Haseth, J.T. Stewart, M.G. Bartlett, "Protein Conformational Analysis under Reversed Phase HPLC Conditions by Particle Beam LC/FT-IR Spectrometry and Electrospray LC/MS", 11th International Conference of Fourier Transform Spectroscopy, Athens, GA, 1997.

Randall T. Bishop, James A. de Haseth,  "Deuterium Labeling for Analysis of Reversed-Phase Protein-Stationary Phase Interaction", 11th International Conference of Fourier Transform Spectroscopy, Athens, GA, 1997.

Randall T. Bishop, Vincent E. Turula, James A. de Haseth, "Structural Characterization of Globular Protein Proteolytic Digest Components by Particle Beam LC/FT-IR Spectrometry and Electrospray LC/MS: β-Lactoglobulin and Cytochrome C", PITTCON, Atlanta, GA, 1997.