Principal Chemist

DR. MD. AMZAD HOSSAIN, Ph.D.

Dallas, Texas, USA

Phone: +717********

Email: ********@*****.***

LinkedIn: https://www.linkedin.com/in/dr-amzad-hossain-37b01323/ PRINCIPAL CHEMIST ANALYTICAL SCIENCE METHOD DEVELOPMENT PHARMACEUTICAL R&D

Accomplished Analytical Chemist and Scientific Leader with more than 25+ years of progressive experience in pharmaceutical analysis, analytical method development and validation, drug discovery, environmental chemistry, and regulatory laboratory operations. Extensive expertise in supporting the pharmaceutical, biotechnology, medical device, environmental, and chemical industries through advanced analytical testing, method development, regulatory compliance, quality assurance, and scientific leadership.

Proven track record of leading complex analytical projects from method development and optimization through validation, verification, technology transfer, troubleshooting, investigation, and client reporting in compliance with FDA, USP, EP, JP, BP, ICH, EPA, GLP, cGMP, and ISO regulatory standards. Highly experienced in analytical characterization of pharmaceutical raw materials, drug substances, finished products, environmental samples, and medical devices using state-of-the-art analytical instrumentation.

CORE SKILLS

I have extensive experience in analytical method development, optimization, validation, and verification in accordance with ICH Q2 guidelines. My expertise includes elemental impurity analysis following USP <232> and ICH Q3D requirements, extractables and leachables studies, pharmaceutical analysis, drug substance and drug product testing, analytical troubleshooting, stability studies, and root cause investigations. I possess comprehensive knowledge of laboratory management, quality systems, SOP development, CAPA implementation, and regulatory compliance under GLP, GMP, ISO 17025, FDA, USP, and ICH standards. In addition, I have demonstrated leadership in managing multidisciplinary scientific teams, providing technical support to clients, preparing technical reports, validation protocols, Certificates of Analysis

(CoAs), and regulatory documentation, while ensuring the delivery of high-quality analytical services that meet industry and regulatory expectations. TECHNICAL EXPERTISE

I possess extensive hands-on experience in the operation, qualification, calibration, troubleshooting, and maintenance of a broad range of advanced analytical instrumentation used in pharmaceutical, biotechnology, environmental, and chemical laboratories. My technical expertise includes ICP-OES, HPLC, UHPLC, GC-MS, Headspace GC-FID/TCD, Automated Liquid Sampler (ALS)-GC-FID/TCD, FT-IR, UV-Visible Spectrophotometry, Ion Chromatography (IC), Total Organic Carbon (TOC) Analyzer, Karl Fischer Titrator, Dissolution Apparatus, Refractometer, Densitometer, pH Meter, and other state-of-the-art analytical instruments. I am highly experienced in instrument qualification (IQ/OQ/PQ), performance verification, preventive maintenance, method transfer, data acquisition and interpretation, software validation, and troubleshooting to ensure reliable, accurate, and regulatory-compliant analytical results. PROFESSIONAL EXPERIENCE

Senior Chemist

Synergy Bioscience, Dallas, Texas, USA

January 2024 – Present

Analytical Testing & Laboratory Operations

Perform routine and non-routine analytical testing for pharmaceutical, biotechnology, and medical device products.

Conduct elemental impurity analysis using ICP-OES in accordance with USP <232> and ICH Q3D.

Perform residual solvent analysis using Headspace GC-FID/GC-MS.

Conduct HPLC/UHPLC, FTIR, UV-Vis, TOC, Ion Chromatography, and Karl Fischer analyses.

Evaluate analytical data using quality control principles and ensure data integrity and traceability.

Prepare Certificates of Analysis (CoAs), validation reports, SOPs, technical reports, and laboratory documentation.

Troubleshoot analytical instruments, hardware, software, and analytical methods.

Maintain laboratory instruments through preventive maintenance and performance verification.

Investigate analytical deviations and implement corrective and preventive actions

(CAPA).

Ensure proper storage, handling, and disposal of laboratory chemicals and samples.

Support internal and external laboratory audits.

Maintain laboratory cleanliness and compliance with laboratory safety and 5S principles.

Train laboratory personnel on analytical methods, instrument operation, laboratory safety, and GMP documentation.

Participate in cross-functional technical teams supporting client projects and process improvements.

Senior Scientist (June 1995 to 2010)

Bangladesh Atomic Energy Commission (BAEC)

Bangladesh.

Since 1995, I have served as a Principal Scientist in the Chemistry Division at the Atomic Energy Center, Bangladesh. Throughout my career, I have made significant contributions to analytical chemistry by providing high-quality analytical services for a wide range of client samples. In addition to my research responsibilities, I have been actively involved in teaching and supervising undergraduate and postgraduate students, mentoring them in both academic and research activities. My research interests encompass natural products chemistry, medicinal chemistry, drug discovery, analytical method development and validation, and environmental chemistry. Over the years, I have conducted multidisciplinary research in these areas, contributing to the advancement of scientific knowledge through the development of innovative analytical methodologies, the characterization of bioactive compounds, and the application of modern analytical techniques to pharmaceutical and environmental investigations

EDUCATION QUALIFICATIONS

Doctor of Philosophy (Ph.D)

Analytical and Medicinal Chemistry

University of Rajshahi, Bangladesh and Malaysia

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