Analytical Chemist(Manager)

***********@***.***

*** **** ****

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

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