Description
QUALIFICATIONS A vast array of experience in QA/QC Analytical and product formulation (Semi Solid and Solid Dosage, Solution, Inhalers) Research and Development management, change management/change leader, project validation senior management * Strong interpersonal skills * Team building/development and cross-functional leadership skills * Effective people management and coaching skills * Customer oriented * Effective collaboration skills * Excellent written and verbal communication skills * Strategic thinking skills * Results oriented (An Achiever and Accountable) Quality and Product Development, Process Engineering, Bioreactors (Fermentation), Biotechnology, ICH Q7 Q8 Q9 Q10 QbD, Analytical Chemistry, Material Science and Characterization, Chemical, Food and Drug Research, Process Validation, Parenteral Drugs Process and Aseptic Filling and Terminal Sterilization Process including Isolators and RABs ISO 5 Class 100-100,000 (FDA E209) clean rooms and Grade A to Grade D (EU GMP Annex 1). Root Cause Investigations, Environmental monitoring Design and Validation using particle counters and microbial samplers including Rapid Microbiological Methods validation and implementation. Clean rooms root cause investigations and Clean Rooms HVAC systems. Quality and Product Development which includes 'hands on' the following: * Method development, validation, experimental design, Computational Chemistry which involved the heavy use of state-of-the-art analytical instrumentation (RP, NP and PP) UHPLC and (RP, NP, PP, GPC) LC with UV-VIS PDA MS/MS: LCMS, LC-MS/MS, Fluorescence, RI, Light Scattering, ELSD and Radioactive Detectors LCxLC/MS/MS. Experience in using GC / FID/TCD/ MS and GCxGC/MS/MS, Head Space/GC and Columns coupling techniques, ICP/OES and ICP/MS methods development and validation. Particle Size characterizations using Dynamic and Static light scattering, Optical Microscopy, SEM and ATM Microscopy material characterization, Thermal Analysis: TGA, DSC, Modulated DSC. Rheological characterizations. Colloid and Surface Chemistry. * Heavy use of Packed and Capillary columns in GC. Developed Narrow Micro, and Capillary HPLC and UHPLC methods. SFC/MS. SFC Exractions. * Bioreactors fermentation optimization, design, research and development. * Expertise includes the following: troubleshooting in HPLC, LCMS, UHPLC, GCMS, GC, Fast GC, Flash chromatography (GC and LC), wet chemistry, protein characteristics and separation, Prep Chromatography, enzymatic methods, FT- NIR, FT-IR. ATR techniques. IR and Reman Spectroscopy/ Microscopy. * Impurity profiling/ isolation/ identification, Rheological, and Texture analysis. Total Organic Carbon (TOC) Analysis. Solid background using USP, AOAC, BP, EP, ASTM, ISO, ICH guidelines. * TQM (SPC), HACCP, FMEA and strict cGMP FDA compliance. Process Validation * Knowledge and experience in material characterizations: Particle size, DSC, TGA, Static and Dynamic Light scattering, Zimm Plots and molecular weight and size. * Knowledge and experience in using MS Office (Excel, Word, PowerPoint, Outlook, Visio, Project) Gantt Charts, Chem. Office, SAP, SAS, STATGRAPHIC PRO, IMAGE PRO, Minitab 17, Spectrum & Opus IR and NIR software and chromatography software such as HP-CHEM STATIONS, TURBO CHROM, Total Chrom, Chromeleon, Empower, EZ Chrom and Millennium. * Knowledge and experience in chemical, food, pharmaceutical, and cosmetics process engineering, Process Analytical equipment Validation, Experienced and Expert in validating new aseptic production facilities equipment and instrumentations, Expert in Pharmaceutical microbiology environmental monitoring and other critical menufecturing process. * Drug substance discovery, and product characterization, * Pharma Kinetics, Pharma Dynamics and In-Vitro Release Testing including Dissolution. * Finding solutions to a variety of technical and analytical challenges in Microbiology and Chemistry. * Knowledge and experience in IQ/OQ/PQ calibration of instrumentations USP<1058>. * Proteins and peptides separation using SDS-PAGE (GEL Electrophoresis), HPCE, HPCE - MS (Capillary Electrophoresis) and HPLC (included Prep. HPLC). REGULATORY KNOWLEDGE AND EXPERIENCE * 21CFR 110, 21CFR 111, 21CFR 210 and 21CFR 211 and 820 cGMP (GXP), regulations in Pharma, Foods, Nutritional Supplements and Biotechnology Industries. ISO 17025, ISO 13485 Experience interpreting and complying with GxP CLIA (CLINICAL LABORATORY IMPROVEMENT AMENDMENTS, 21CFR 58 Good Laboratory Practice, Statistical Process Control (SPC). Lead FDA Audits * ICH and VICH and EU GMP guidelines. * FDA Guidelines for many aspects of the regulation in Foods, Drugs and Nutritional. Supplements. CMC certified. Aseptic manufacturing guidance EU GMP Annex 1. * USP, EP, BP, JP Guidelines for Drugs and Nutritional Supplements. * FCC Foods Chemical Codex Guidelines and monographs for foods materials. * Developed and implemented HACCP FMEA and SQF systems. * Supplier Audit experience with 21CFR210, 211, 110 (GMP), 111 ISO 17025, 21CFR58 (GLP), SQF, USP<1058> DQ/IQ/OQ/PQ, CSV, ISO13485 related to equipment qualifications (Lab/Process Instrumentation), FDA QSR. * Implemented CAPA (Corrective and Preventive Action), and CAPA systems. RECENT WORK HISTORY
Work Experience
Accomplishments
Keywords
