Wes Workman Email & Phone Number

Greater St. Louis Area

• Current consulting projects include 1) commercial analytical development, validation, and transfer, 2) writing/editing regulatory submissions, 3) interaction with regulatory agencies and responding to queries, and 4) development and qualification of reference materials for analytical testing. • Member, USP Quality Advisory Group• Member, Editorial Board, PDA Journal of Pharmaceutical Science and Technology• Journal Reviewer, Analytical and Bioanalytical… Show more • Current consulting projects include 1) commercial analytical development, validation, and transfer, 2) writing/editing regulatory submissions, 3) interaction with regulatory agencies and responding to queries, and 4) development and qualification of reference materials for analytical testing. • Member, USP Quality Advisory Group• Member, Editorial Board, PDA Journal of Pharmaceutical Science and Technology• Journal Reviewer, Analytical and Bioanalytical Chemistry Show less

United States

Analytical consultant to a team providing CMC support to the pharmaceutical industry

Greater St. Louis Area

• Analytical lead for commercial contract manufacturing• Bioassay development and analytical cell licensing• Analytical lead for process observation and analytical characterization project ($42 million impact)• Lead for bovine spongiform encephalopathy (BSE) prion and viral clearance studies.• Analytical team lead for multiple commercial products

Greater St. Louis Area

• Pfizer analytical validation and technical transfer subject matter expert• Pfizer heparin technical lead during the 2007 heparin contamination crisis. No Pfizer heparin entering the market was found to have contamination• Pfizer technical lead producing additional experimental data and response to FDA query on a potential adverse event• Analytical team lead for multiple commercial products

Greater St. Louis Area

• Analytical Lead on the team that obtained FDA and EMEA approval of Somavert® (pegylated growth hormone antagonist)• Led the analytical team developing and validating the analytical methods for leridistim SC-70935, a recombinant chimeric dual G-CSF and IL-3 receptor agonist• Analytical team lead for multiple commercial products

Greater St. Louis Area

• Led a team of six postdoctoral associates to develop and validate the analytical methods for daniplestim synthokine SC-55494 (cytokine), an interleukin-3 (IL-3) receptor agonist• Director of the analytical section that obtained FDA approval of Posilac®, recombinant bovine somatotropin (growth hormone) for enhanced dairy production. Posilac® was a pioneering product in veterinary products produced through recombinant DNA technology.• Developed and published best-practice early residual… Show more • Led a team of six postdoctoral associates to develop and validate the analytical methods for daniplestim synthokine SC-55494 (cytokine), an interleukin-3 (IL-3) receptor agonist• Director of the analytical section that obtained FDA approval of Posilac®, recombinant bovine somatotropin (growth hormone) for enhanced dairy production. Posilac® was a pioneering product in veterinary products produced through recombinant DNA technology.• Developed and published best-practice early residual DNA test. Workman, W.E.1995."Sample Preparation and Residual DNA Analysis of Biopharmaceuticals", Pharmacopeial Forum 21(2): 479 - 484.• Member of the research team that first reported misincorporation of norleucine for methionine in E. coli produced recombinant proteins. Bogosian, G., B.N. Violand, E.J. Doward-King, W.E. Workman, P.E. Jung, and J.F. Kane.1989."Biosynthesis and Incorporation into Protein of Norleucine by Escherichia coli". Journal of Biological Chemistry, 264(1):531-539 Show less

Postdoctoral Research Associate, Biochemistry And Molecular Biology

Doctor Of Philosophy, Microbiology

Bachelors Of Science, Medical Technology