- Lead Scientist with extensive experience maintaining communication across functional teams.
- Background includes drug product formulation and analytical chemistry research, development, analysis, characterization, qualification, validation of small organic molecules, peptides, and proteins.
- Responsive, well - organized professional, collaborating across teams to achieve objectives while managing multiple concurrent projects and promoting continuous improvement mindset.
- Laboratory Resource Management | Quality-by-Design Product Assay Procedures |:
- Assay, Process & Instrument Troubleshooting | Root Cause Identification & Resolution |:
- Chemical Analysis & Characterization | Standard Operating Procedure (SOP) & Work Instruction Creation |:
- New Drug Application (NDA) Submission to Food & Drug Administrative (FDA):
- High / Ultra Performance Liquid Chromatography (H/UPLC) |Reversed Phase (RP)| Size Exclusion (SEC) | Ion Exchange (IEX):
- Mass Spectrometer-UPLC Tandem | GC Chromatography | Spectrophotometers | Peptide Synthesizer:
- Differential Scanning Colorimeter | Nuclear Magnetic Resonance (NMR) | Amino Acid (AA) Analyzer:
- Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE) | Western Blot | Lowry Assay:
- Enzyme-Linked Immunosorbent Assay (ELISA) | Microsoft Office (Word, Excel, PowerPoint)
Confidential, Menlo Park, CA
Scientist - Analytical Research and Development
- Supported clinical assessment by leading design of experiment of ATPs used for analysis of active pharmaceutical ingredient (API) content, related substance assay, excipient, product impurity, in-vitro dissolution, leachable characterization, qualification, work instruction, and validation reports.
- Supervised and contributed to in-vitro dissolution assay profile development, lot release, process scale-up, product stability testing, assays and instruments troubleshooting, ATPs transfer, QC associates, and regulatory requirements studies.
- Ensured test procedure, qualification, validation, and data and report accuracy prior to NDA submission by reviewing documents and analyzing data.
- Reduced downtime and ensured compliance by managing cGMP equipment preventive maintenance, calibration, change control, and other quality systems.
Confidential, Emeryville, CA
Scientist II - Manufacturing Science and Technology Development (MSTD)
- Facilitated timely technology transfer to manufacturing QC by leading diagnostic peptide synthesis (40+ amino acids sequence), purification, chemical analysis, characterization, process scale-up, preparation of SOPs, work instructions, qualification, validation, and reporting.
- Enabled process development for genetic engineering of yeast strains saccharomyces cerevisiae proteins, including design of experiment (DOE) for total proteins qualitative and quantitative analysis, chemical characterization, reagent development, bulk fill, improvement, qualification, validation, reports, and technology transfer to manufacturing QC.
- Supported manufacturing by leading root cause analysis, failure modes and effects analysis (FMEA), process improvements, proven acceptable range (PAR) studies, lifecycle qualification studies, and regulatory requirements deviation and unanticipated events investigations.
Confidential, Menlo Park, CA
Scientist II - Analytical Research and Development (AR&D)
- Guided development of assay methods and procedures - API extraction, qualitative and quantitative of API content in formulation, related substances, excipients, in-vitro dissolution, troubleshoot assays and instruments, QC analysis, qualification, and report.
- Supervised cGMP equipment calibration, preventive maintenance, change controls, and other quality systems, decreasing downtime and verifying compliance.