Performing all HPLC analyses to support stability testing, method development, and method validation for a penicillin allergy test kit. Participating in the synthesis of amoxicillin sodium as well as providing analytical support to scale up the material. Responsible for analytical and quality work in support of module 3 NDA submission documents.Wrote and executed operation qualification and performance qualification for HPLC's in the laboratory.Writing SOP’s, testing protocols,… Show more Performing all HPLC analyses to support stability testing, method development, and method validation for a penicillin allergy test kit. Participating in the synthesis of amoxicillin sodium as well as providing analytical support to scale up the material. Responsible for analytical and quality work in support of module 3 NDA submission documents.Wrote and executed operation qualification and performance qualification for HPLC's in the laboratory.Writing SOP’s, testing protocols, and development reports. Summarizing results in MS PowerPoint for presentation to the project team. Show less

•Performing analytical testing (e.g. assay, purity, content uniformity, dissolution, etc.) on drug product samples manufactured in India and China.•Ensuring conformance with specifications before drug products are released onto the market.•Maintaining and storing the laboratory supplies to ensure efficiency and effectiveness in the laboratory.

Performed the analytical testing to support long-term and accelerated stability studies on inhalable insulin dry powder. Some of the analytical tests included: potency and related substances by HPLC, Karl Fischer titration, SEC, GC, and particle size distribution by cascade impaction. In addition to that my responsibility included writing technical reports i.e., analytical test methods, validation reports, and SOP's. Issued an SOP on controlled worksheets that improved the recording and… Show more Performed the analytical testing to support long-term and accelerated stability studies on inhalable insulin dry powder. Some of the analytical tests included: potency and related substances by HPLC, Karl Fischer titration, SEC, GC, and particle size distribution by cascade impaction. In addition to that my responsibility included writing technical reports i.e., analytical test methods, validation reports, and SOP's. Issued an SOP on controlled worksheets that improved the recording and tracking of laboratory data in QC. I was also responsible for the managing and qualifying the reference standards to be used by the analytical and quality control departments. In my time there I developed and validated an assay and related substances test method for the inhalable insulin powder. Show less

• Developed robust and rugged methods for the determination of potency and purity of orally available proteins/peptides using reversed phase HPLC and size exclusion chromatography.• Evaluated ion exchange chromatography as an orthogonal analytical technique for protein assay method that resulted in a better understanding of the protein.• Evaluated potential degradation pathways/kinetics of degradation of proteins/peptides via well designed forced degradation studies (i.e., influence pH,… Show more • Developed robust and rugged methods for the determination of potency and purity of orally available proteins/peptides using reversed phase HPLC and size exclusion chromatography.• Evaluated ion exchange chromatography as an orthogonal analytical technique for protein assay method that resulted in a better understanding of the protein.• Evaluated potential degradation pathways/kinetics of degradation of proteins/peptides via well designed forced degradation studies (i.e., influence pH, temperature, metals, oxidation)• Performed long term and accelerated stability studies on drug product that supported formulation development.• Determined changes in protein secondary structure using FTIR analysis (effect of pH, temperature and pressure).• Performed fast HPLC method development utilizing Waters AMDS/Drylab and UPLC.• Presented method development optimization strategies and analytical project summary activities to group and fellow colleagues. Show less

• Successfully transferred aerodynamic particle size distribution test procedure for dry powder and metered dose asthma inhalers to quality control department.• Participated in pre-approval inspection team that verified method validation packages prior to regulatory submission.• Prepared and released departmental SOP for calibration of pressure gauge flow meters and HPLC/UV detectors.• Maintained the safety and daily operation of the laboratory that ensured compliance with the… Show more • Successfully transferred aerodynamic particle size distribution test procedure for dry powder and metered dose asthma inhalers to quality control department.• Participated in pre-approval inspection team that verified method validation packages prior to regulatory submission.• Prepared and released departmental SOP for calibration of pressure gauge flow meters and HPLC/UV detectors.• Maintained the safety and daily operation of the laboratory that ensured compliance with the current GLP/GMP guidelines.• Performed HPLC standard and sample solution stability studies for drug product potency method validation.• Performed HPLC dose uniformity and potency analysis for active ingredient.• Released clinical batches of metered dose inhalers and dry powder inhalers.• Developed, validated, and troubleshot aerodynamic particle size distribution test methods for metered dose asthma inhaler.• Voluntarily implemented coulometric Karl Fischer system in laboratory and coordinated IQ, OQ, and PQ for the instruments.• Maintained and troubleshot Agilent, Shimadzu, and Waters HPLC systems, Andersen cascade impactor, and Karl Fischer moisture analyzer.• Served as a resource for peers on analytical questions related to cascade impaction technique and HPLC troubleshooting. Show less

• Investigated the effect of different acidic modifiers/type, concentration of salt additives, and pH upon the retention of basic compounds/pharmaceuticals.• Designed experiments for advanced hands-on reversed phase HPLC method development short courses.• Developed and trained undergraduates in experimental design, instrumentation, data acquisition, and results interpretation.• Supervised general chemistry lab sections on experimentation, techniques, and safety.