Paul W. Stoker Home: 770-***-****
Fayetteville, GA 30215 email@example.com
Summary of Skills and Experiences:
Over 28 years of Pharmaceutical Analysis, with the majority of the years in manufacturing support.
Participated in FDA P.A.I., Annual, and Consent Decree Audits, have also interacted with EMEA and The Pharmaceuticals and Medical Devices Agency (Japan).
Familiar with ICH Guidelines and FDA documentation practices regarding cGMP expectations.
Experienced with HPLC, UPLC, LC/MS/MS, GC, GC/MS, Maldi-TOF, Ion Trap MS, Flow Cytometry, and have used USP methods for raw material testing.
Oversaw method development and validations.
Oversaw testing efforts in the support of OOS investigations, CAPAs, process and cleaning validations, and manufacturing investigations.
Have worked with small molecules, large molecules (proteins), sterile parenterals, and living cell analysis.
Ph.D., University of Nebraska, Lincoln, Biochemistry, 1994.
Dissertation Title: Heavy-Atom Isotope Effects for Enzymes of Glutamine
M.S., Brigham Young University, Zoology, 1984.
Emphasis in Toxicology and Statistics.
B.S., Brigham Young University, Chemistry, 1982.
July 2018 to September 2019
Quality Control Director. SCA Pharma, Windsor, CT.
Responsible for the Analytical Laboratory in a compounding facility. The Analytical Laboratory performs Potency and Identification testing on the finished products.
Oversaw the method development activities. Have performed early development work showing that 32 compounds could be analyzed by a single method. Have validated 10 different UPLC methods, with three methods having multiple compounds in the method, using PDA and MS detectors.
Implemented special report formatted report using the Empower software.
Have written a number of extensive investigational reports as part of OOS investigations.
Worked on improving the DEA tracking system.
October 2017 to June 2018
Quality Control Director. Pharmedium, Memphis, TN.
Responsible for Analytical and Microbiological Laboratories in a sterile facility. The Analytical laboratory was responsible for the finished product testing of the final product to insure the potency of the products. The Microbiological Laboratories performed sterility, endotoxin, and environmental monitoring activities.
Performed method development and transfer activities.
Improved the performance of the laboratory by changing procedures and streamlining the reporting functions by using more of the capabilities of the Empower software.
Have improved the training program in the Analytical laboratory.
Doubled the staff of both laboratories, to a staff size of 74 people, with 5 direct reports.
Established a DEA tracking software system for reference standards and samples.
April 2015 to September 2017
Senior Quality Director. Acella Pharmaceuticals, Alpharetta, GA.
Responsible for the quality assurance activities, which includes batch release, packaging records, labeling, and final release, performed by contractors.
Oversaw the stability, complaint, external audit, and vendor certification programs.
March 2014 to September 2014
Quality Control Director. Cognate BioServices, Inc., Memphis, TN .
Oversaw the chemistry and microbiology testing activities in a Sterile Immunological Manufacturing Facility.
Outlined efforts to increase the manufacturing and laboratory performance.
August 2013 to March 2014
Quality Control Director. Oso Biopharmaceutical, Albuquerque, NM.
Lead the Chemistry and Microbiology Departments in a Sterile Manufacturing Facility. The Microbiological Department was responsible for environmental and personnel monitoring, and sterility testing of the final products. The Chemistry department was responsible for raw material, in-process, and final product testing.
Performed method development and transfer activities.
Evaluated staffing, facilities, and instrument requirements to increase efficiency and compliance.
Replaced a significant number of obsolete instrumentation, implemented new Empower 3 software, which resulted in automated data processing of HPLC and UPLC analysis, and added new instrumentation to allow rapid identifications of incoming materials (Cobalt RapidID instrument).
Began the modifications of the Chemistry laboratory, so that Schedule 4 and 5 compounds could be safely isolated in a containment laboratory facility.
Was able to successfully implement “first in first out” testing in the Raw Material testing area, which resulted in the timely testing and release of all raw materials to manufacturing.
Evaluated Laboratory Information Management Systems (LIMS) for implementation.
June 2010 to September 2012
Director, Quality Control Laboratory. Dendreon, Union City, GA.
Hired 62 people, organized into 9 groups, and managed a 24 hour/6 day operation.
Implemented training program using a mentoring program and a training coordinator.
Reviewed technical documents, including: protocols, process and cleaning validation reports, and method validation and transfer reports.
Increased efficiencies by rewriting methods and cross training laboratory personnel on all methods.
Familiar with flow cytometers, hematology analyzers and kinetic endotoxin techniques.
Evaluated LIMS systems to improve the output of the laboratory.
Familiar with Regulatory requirements for Blood products, including microbial environmental and personnel monitoring, and sterility assurance testing of the product.
Lead initiatives to eliminate excessive testing.
Technical expert for FDA audit.
May 2008 to June 2010
Director, Quality Control Laboratory and Analytical Services, Nektar Therapeutics, Huntsville, AL.
Managed the stability program and wrote the stability reports.
Cross trained all laboratory staff to increase effectiveness of laboratory personnel.
Added new analytical instrumentation to resolve problematic methods (MALDI-TOF).
Wrote a significant number of scientific papers, OOS investigations and Responses to client audits.
Preformed final review of QC data before release to QA.
Familiar with water testing requirements (for WFI and USP Purified Water).
Served as a technical expert with client and FDA auditors.
Knowledgeable of HPLC instrumentation, performing size exclusion and reverse phase chromatography.
February 2005 to March 2008
Associate Director, Quality Control Laboratory, Mylan Laboratories, Morgantown, West Virginia.
Supervised the QC laboratory on the second shift, testing generic pharmaceuticals by HPLC and USP methods.
Implemented a Metric program by using multiple unconnected data systems. Identified key performance issues, using these metrics.
Interviewed over 435 people and was responsible for hiring 100 people.
Used Trackwise and Documentum systems.
Decreased cycle time, by prioritizing the work load and increasing testing efficiency.
October 2003 to July 2004
Global Director, Quality Control Laboratories, Boston Scientific Corporation, Maple Grove, Minnesota.
Responsible for two QC laboratories at different sites.
Served as a Scientific Subject Expert during an FDA audit.
Improved laboratory systems, increasing testing proficiency, and reducing retesting time.
Created Analytical Method templates, to standardize data entry and report generation.
Involved in the pre-launch and post-launch of the TAXUS Express2 drug-coated stent product.
Familiar with the Medical device regulations.
Provided weekly metrics on the laboratory’s performance.
Evaluated two Chromatographic data archive and retrieval systems (Nugenesis 6.0 and LIMS (Matrix plus).
April 2000 to December 2002
QC Analytical Chemistry Department Manager, Aventis Behring, Kankakee, Illinois.
Lead the QC laboratory out of a FDA Consent Decree.
Served as Subject Matter Expert on two FDA audits.
Implemented modern analytical instrumentation, Mass Spectrometers: Ion Trap, ICP-MS, and MALDI-TOF.
Reviewed Protocols, Reports, OOS investigations, and manufacturing investigations.
Supervised the development and validation of over 45 methods.
Reduced the number of non-confirmed OOSs.
Eliminated redundant testing requirements, using statistics.
Reduced training requirements.
September 1995 to April 2000
Director / Associate Director / Drug Substance Characterization Manager, Oread Laboratories, Inc., Lawrence, Kansas.
Responsible for building four great teams, with 42 people, analyzing pharmaceutical products.
Familiar with all cGMP regulations dealing with pharmaceutical products.
Monitored the output of the laboratory to project the future staffing requirements.
Streamlined and standardized the reporting formats of the laboratory.
Interacted with client and FDA auditors during product reviews.
Supervised the operation and maintenance of a Micromass Quattro II (LC/MS/MS).
August 1994 to September 1995
Post-Doctoral Research Associate, University of Nebraska, Lincoln.
Performed protein structural determinations using mass spectrometry, by LC-MS (using FAB and electrospray ionizations).
September 1989 to July 1994
Graduate Student, University of Nebraska, Lincoln.
Taught Molecular Biological Techniques laboratory classes, which included; ELISA, SDS-PAGE. Western Blots, Agrose gels, infection and plasmid isolations, and protein purifications.
Served three semesters as the teaching assistant for the Biochemistry classes.
Emphasis of graduate study was in enzymology, enzyme kinetics, organic synthesis, and bio-analytical chemistry. Research work examined chemical transition states for reactions catalyzed by biological enzymes using Isotope Ratio Mass Spectrometry.
November 1987 to August 1989:
Organic Extraction Laboratory Supervisor, Harris Environmental Technologies, Lincoln, Nebraska.
Trained people to perform environmental and pesticide analysis by GC and HPLC.
May 1985 to October 1987:
Analytical Chemist, Environmental Research Center, QC Laboratory, UNLV, Las Vegas, Nevada.
Operated and maintained a Finnigan 1020 OWA mass spectrometer; various gas chromatographs.
Analyzed pesticides, PCBs, and volatile organic samples (CLP program). Performed Special Projects.
August 1984 to March 1985:
Technical Sales Representative, Alde Chemicals Inc., Fresno, California.
Sold and provided technical water treatment services to industrial businesses.
August 1982 to August 1984:
Research and Teaching Assistant, Brigham Young University, Provo, Utah.
Taught Environmental Toxicology and Basic Human Anatomy classes.
Conducted toxicological experiments with mammalian and aquatic organisms using environmental contaminates. Analyzed the results using statistical methods.
September 1980 to August 1982:
Research Assistant and Technician, Alpine West Laboratories, Provo, Utah.
Operated gas chromatographs (HP, Perkin-Elmer, and Carlo Erba GCs) in the identification of polycyclic aromatic compounds found in fish and dust samples. Performed vapor pressure measurements for the U. S. Department of Commerce.
--Deviation Investigations, CAPAs, and Change Control, Skillsplus, Nektar, Jan. 2010.
--Root Cause Analysis: Understanding Failures, Exceptions, and Nonconformances, Nektar, Oct. 2009.
--Trackwise, March 2006.
--Developing Financial Acumen for Non-Financial Managers, Excidian, Jun. 2005.
--Managing for Success and within the Law, and Successful Interviewing, Boston Scientific Leadership Series, Jan. 2004.
--Leadership: Facilitating Change, Guiding Conflict Resolution, DDI, Sept. 2002.
--Validation and Qualification Compliance Requirements, Pharmaceutical Compliance Associates, Jun. 2002.
--Basic Statistics, A Comprehensive Look at O.O.S. Guidance and Regulations, Assay Validations, and Design of Experiments, Torbeck and Associates, 2000-01.
--FDA Compliance/Inspections: Trends and Issues, and U. S. vs. Barr Laboratories, Oct. 2001.
--ASMS workshop in Combinatorial Chemistry, October 1997.
--Project Management, Keller Graduate School of Management, June 1997.
--Operations Training Course for Micromass Quattro II mass spectrometer, Nov. 1996.
--cGMP, 21-CFR-210, and 21-CFR-211 Training, Starting 1995 and annually since this date.
--Operations Training Course for VG Organic Autospec mass spectrometer, Jun. 1995.
--Waters HPLC Maintenance and Trouble Shooting, 1988.
--Quantitative Mass Spectrometry, ASMS, May 1987.
--Operation of the Finnigan MAT 1020/OWA GC/MS system, March 1986.
Widaman Trust Distinguished Graduate Assistant Award, University of Nebraska, 1992.
Most Outstanding Thesis of the Department of Zoology and of the College of Biological and Agricultural Sciences, Brigham Young University, 1984.
Dr. James Kelly Award, Outstanding Analytical Chemist 1982, Department of Chemistry,
Brigham Young University.
Stoker, P. W., O'Leary. M. H., Boehlein, S. K., Schuster, S. M., and Richards, N. G. J., "Probing the Mechanism of Nitrogen Transfer in Escherichia Coli Asparagine Synthetase by using Heavy Atom Isotope Effects,” Biochemistry, 35, 3024-3030, (1996).
Smith, D. L., Zhang, Z., Dharmasiri, K. and Stoker, P., “Detecting Conformations and Conformational Changes by Hydrogen Exchange and Mass Spectrometry,” Protein Science, 4, suppl. 2, 102, (1995).
Stoker, P. W., Larsen, J. R., Booth, G. M., and Lee, M. L., "Pathology of Gill and Liver Tissues from
Two Genera of Fishes Exposed to Two Coal-Derived Materials (Thesis)," Journal of Fish Biology, 27,
Later, D. W., Barrclough, S. A., Lucke, R. B., Pelroy, R. A., Stoker, P. W., and Booth, G. M., "Analytical and Chromatographic Methods for the Determination of Cyano Polycyclic Aromatic Hydrocarbons in Coal-Derived Materials,” Proceedings of the 8th International Symposium on PAC. Battelle Laboratories, Columbus, Ohio 1983.
West, W. R., Smith, P. A., Stoker, P. W., Booth, G. M., Smith-Oliver, T., Butterworth, B. E., and
Lee, M. L, "Analysis and Genotoxicity of PAC found in Polluted River Sediment," Proceedings of the 8th International Symposium on PAC. Battelle Laboratories, Columbus, Ohio 1983.
Vassilaros, D. L., Stoker, P. W., Booth, G. M., and Lee, M. L.," Capillary Gas Chromatograph Determination of Polycyclic Aromatic Compounds in Vertebrate Fish Tissue." Analytical Chemistry, 54, 106-112, (1982).