Scientist / Senior Research Specialist
West Lafayette, In
• Dissolution/auto-sampler/UV-VIS system integration optimization under cGMP • Liquid-state 1H, 13C, 19F, and 31P NMR analyses• SSNMR sample prep• HPLC, UV-Vis, IR, GC, and Dissolution analyses• Lean Six Sigma 5S (lab organization) team member• LIMS trainer for new employees – customized LIMS used for all aspects (billing, data archiving, sample tracking, reports, etc.) of business• Execution of user software validation scripts for Agilent UV-Vis and Dissolution instruments for cGMP compliance including 21CFR11• Performed GC software (ChemStation) periodic review• Authored SOP revisions for cGMP qualifications and analyses: HPLC, GC, UV-Vis, and Dissolution• Project Leader of multiyear stability project• Solved complex instrumental issues for UV-Vis (type of qualification standard matched to angled or straight incident beam, additional power supply filtering added, and instrumental specific optical and electrical variation accounted for on an ad hoc basis)• cGMP lot release testing• Dissolution and GC system troubleshooting and maintenance• Interdepartmental research leader (surface induced solid form change evaluation by XRPD, IR, and Raman)