Clayton, NC *7520
Andre′ Randel Johnson
Experience 05/2005–present Wyeth Sanford, NC
Manager, GMP Operations, Vaccine Analytical Development
• Direct the laboratory responsible for all GMP testing for clinical trial vaccine candidates (including polysaccharides, proteins, and conjugates).
• Provide coaching and performance reviews for 7-10 Scientists.
• Review analytical methods for technical content and GMP compliance.
• Establish policies/procedures for the Laboratory.
• Perform troubleshooting and optimization of analytical methods.
• Review and approve analytical results.
• Lead investigations of OOS and atypical results
• Direct the Reference Standard program for Vaccine Analytical Development.
• Lead the group responsible for ensuring the procurement, formulation, filling, and aliquotting of reference materials and controls.
• Establish policies for generation, characterization, storage, and inventory management of reference materials.
• Direct the method validation and transfer activities for vaccine candidates.
• Review method qualification documents and ensure the methods are scientifically sound.
• Establish policies for method validation and transfer.
• Review and approve IQ/OQ/PQ protocols and reports
• Implemented a variability reduction project to improve the quality of the data.
• Led a cross functional team that facilitated the transitioning of the reference materials to the commercial QC organizations.
• Led cross-site teams responsible for method validation and transfer for multiple projects.
06/2001–05/2005 GlaxoSmithKline Zebulon, NC
Senior Quality Assurance Scientist
• Coordinated the daily activities of 6-8 analytical chemists.
• Performed troubleshooting and optimization of analytical methods.
• Performed and documented investigations of OOS and atypical results.
• Reviewed analytical methods and product specifications
• Performed review and approval of Chemistry Batch records
• Coordinated testing in support of cleaning validation
• Assisted in optimizing the design of the cleaning validation program
05/1998–06/2001 Merck Manufacturing Division Wilson, NC
Quality Control Chemist
• Performed analysis for release and stability samples, including physical testing such as TLC, Karl Fisher moisture analysis, iron oxide analysis
• Interpreted testing data and provide timely reports
• Trained team members on product testing methods
• Optimized method and led method transfers.
01/1993–05/1998 Bayer Corporation Clayton, NC
Assistant/Associate Chemist-Quality Assurance
• Analyzed raw materials, in-process and final container plasma products
• Developed and validated methods
Skills HPLC, GC, IC, Dissolution, Spectroscopy (IR/UV/Vis), Wet Chemistry, CE, Microsoft Word, Microsoft Excel, SQL and Labware LIMS, Empower(I/II), TotalChrom, Green Belt Certification
Education 1988–1992 Guilford College Greensboro, NC
• Bachelor of Science in Physics with a minor in Chemistry