Over 24 Years of Experience in Pharmaceutical and Biotechnology IndustriesDepartments: Research and Development, Analytical, Quality- Analytical Method Development, Validation, and Technical Transfers- Protein Chemistry/Characterization Techniques for Protein and Peptide Drug Products- GMP Release and Stability Study Oversight- USP Compendial Methods, Method Verification- Project Coordination- Internal/External Auditing - Analyst and Laboratory Management Analytical and Microbial Methods Include;- HPLC Methods; SEC, RP, IEX- GPC and ELS Detection- SEC-MALS- Laser Diffraction Analysis (Particle Size)- Gel Electrophoresis; (IEF, Native, and SDS-PAGE: Coomassie and Silver Staining)- Western Blot Analysis- Capillary Electrophoresis: (size, charge)- Circular Dichroism- Protein Concentration Methods; BCA, DC-BioRad, Lowry- Dissolution; USP-2- Compendial; USP Sterility, Bioburden, Endotoxin, TOC, Absorbance, pH, Osmolality, Moisture- Microbial; Environmental Monitoring and Speciation by MIDI-GC, Vitek, and API- Cleaning Validations; Processes, Recovery Studies, and Analytical Methods-SME on LIMS Stability Management Systems: SLIM, iStability Database Software Systems