Mohammad Miah

Background

About Mohammad Miah

CAREER SUMMARY I have 25 years of experience in the pharmaceutical industry as an analytical and managing chemist. My experiences also include Reviewer, Analytical Trainer, Method Development and Validation, Lab and project management. I have a strong understanding of current FDA regulations, cGMP, ICH guidelines and USP/NF compendium methods. I am versatile, adaptable and willing to tackle new responsibilities, flexible in carrying out varied assignments under pressure in a high quality work environment. I am capable of managing multiple projects from the drug substance evaluation to the submission of the final report to the regulatory affair department. I am business and results oriented, and consistently exceeding goals and expectations. CORE COMPETENCIES Managing a group of scientists in Analytical R&D department Method development, validation and optimization, method verification and method transfer Laboratory Deviation and Investigations for out of specification and out of trend result cGMP, ICH,USP, NF, EP, BP, Japanese Pharmacopeia and FDA regulations Documentation, method validation, verification and transfer protocols and reports generation HPLC, UPLC,GC, FTIR, Online UV dissolution, Online HPLC dissolution, UV/VIS spectrophotometers, particle size, Ro-Tap Sieve analyzer, Computrace moisture analyzer, Ohaus moisture analyzer, Viscosity, TLC Instrument calibration, maintenance, troubleshooting, verification and validation, IQ, OQ, PQ Chemical and instrument analysis for drug substances (API), intermediates, finished products and raw materials testing according to USP/ NF, EP and pharmacopoeia SAP, LIMS, Empower, GXPharma-pharmaceutical system analysis, design, development and implement Proven communication and writing skills, authored SOP and technical reports SAP, LIMS, Empower, GXPharma-pharmaceutical system analysis, design, development and implement Proven communication and writing skills, authored SOP and technical reports