Mohammad H Rahman

*** ********* ***, *****, ** **473

718-***-**** (Home), 347-***-**** (Cell)

adcz4w@r.postjobfree.com

Professional Summary j

Creative professional with 17 years of extensive experience in Pharmaceutical, Biotech, and Consumer Healthcare industries.

Talents include conducting laboratory research, analytical method development and validation for various formulated drug products & drug substance, Large and Small Molecules (solid and liquid dosage form, mitered dose inhaler and raw materials).

Provided analytical support to raw material and stability and release testing of early stage vaccine /CMC-544(Calichaemicin) Antibody Drug Conjugate through qualifying and transferring assays required for testing/characterizing intermediate, in-process, formulated and final sample.

Experienced in validating and qualification of analytical assays for proteins and large biomolecules using separation techniques, SEC, NP and RP Chromatography (HPLC, GC), and stability testing, release testing, process validation, raw material testing, wet chemistry and Compendial methods (USP/EP JP ACS).

Significant analytical method development and validation experience with HPLC/GC, dissolution, UV/Vis, Elisa, Aggregate, Oligosaccharide finger print and other analytical techniques and method transfer to both internal and external groups.

Characterize drug products, impurities and various drug product formulations.

Strong compliance mindset including cGxPs (cGLP, cGMP), FDA, DEA and OSHA regulations and SOPs. Experienced in laboratory investigations and documentation of OOS/OOT results in Trackwise / SAP system.

Implemented instrument qualification protocols for calibration and qualification of HPLC, dissolution baths and UV spectrophotometers.

Experienced in LIMS Labware system.

Designed template for test in LIMS Labware.

Designed analytical methods, Protocol for Validation and reports.

Reviewed pre-approval inspection readiness audits during FDA inspection for ANDA submission.

Core Qualifications j

●Extensive experience in Method development, Method Validation, Stability, Release testing, Wet Chemistry, Raw materials, Dissolution, and Process validation.

●Hands on experience in instruments qualification included IQ, PQ and OQ.

●Experience in Compendial Methods Included (USP / NF, EP, JP, ACS and Korean Pharmacopoeia).

●Detailed knowledge in regulatory compliance, cGxPs (cGLP, cGMP), ICH and FDA, EMA.

●Reports generation and analysis

●Pre Approval Inspection readiness audits during FDA inspection

●Capability and experience to work independently with strong decision- making capability

●Hands on experience in instruments included (HPLC, GC, FTIR, UV, Refractive Index, Polarimeter, Karl Fisher, Particle size Analyzer and also familiar with GC-MS and AA.

●Proficient in Instrument related software included (Empower2,Atles,Turbochrom, Chemstation, Omnic, Soft Max for Plate Reader and IRsolution).

●Lean Six Sigma

●SAP, Trackwise, PDOCS, GXPharma, LIMS Labware, Nautila

●Proficient in Microsoft Office Suite (MS Word, Excel, Power Point, Outlook Express)

Experience

Polygen Pharmaceutical, Edgewood, NY Jul 2017 to present

Manager

Leading the Projects

Primary responsibility is to provide analytical support to Method development, Method Validation, Stability Study, supporting ANDA batch, release testing for various formulated drug product using HPLC, GC, FTIR, Karl fisher, TLC, UV and wet chemistry

Design Protocol for Validation and Execute

Prepare Validation report

Prepare COA,QSS & QSP

Performed in process, finished product and stability testing (Assay, Content Uniformity, Blend Assay, Related Compound, Organic Impurities and Dissolution analysis using HPLC, GC, UV-VIS, Dissolution System, utilizing, Empower 3 software, other analysis utilizing KF, FTIR and TLC

Generate data for ANDA submissions and taking part in the reviewing process.

Conduct laboratory investigations

Trained junior scientist

Perform In-house standard qualification and vendor qualification

Troubleshooting method and instrumentation problems

Supporting API and Excipients release

Eurofins, Lancaster, PA Jan 2017 to Jun 2017

Sr. Scientist

Primary responsibility was to perform protein and impurities analysis, Peptide mapping using various analytical techniques such as HPLC, UV using Atles and Nautilus, documenting work as required for GMP compliance, troubleshooting method and instrumentation problems, performed investigation, developing and executed validation plans, carried out method transfers and feasibility studies and trained technical staff.

Pfizer (formerly Wyeth) – Pearl River, NY Mar 2006 to Jul 2016

Scientist, Biotech / Vaccines

Primary responsibility was to provide analytical support to Method development, Method Validation, Stability Study, Raw material and and release testing of early stage vaccine and CMC-544 (Calicheamicin) & Mylotarg through validating, qualifying and transferring assays required for testing/characterizing intermediate, in-process formulated and final samples utilizing different techniques FTIR, Wet Chemistry, Lysozyme Binding Capacity and Amino Acids Identification using HPLC/Empower/LIMS,, Elisa, Aggregate, Oligosaccharide finger print/using HPLC, residual solvents (Calicheamicin) /Assays using GC, assays using UV and potentiometric titration, Heavy Metal, Arsenic, Moisture using KF and TGA, LOD, ROI, and Refractive Index followed by Compendial USP/EP/ACS/JP method.

Participated in reviewing Compendial Methods. Performing verification and validation of Compendial USP/EP/ACS/JP method used in raw material testing and participating in instruments qualification.

Initiate laboratory investigations and documentation of OOS/OOT results and evaluate deviations in trackwise / SAP system.

Routinely testing protein content and total calicheamicin using UV for Mylotarg and CMC-544 and Strength and Identification test using HPLC for Crude oil.

Participated in Bridging Study (Validation) and transfer method to external Lab for protein content and total calicheamicin with

Alpharma –Elizebeth, NJ Jun 2003 to Mar 2006

Research Scientist 2

Conducted laboratory research, analytical method development and validation for various formulated drug products,

Performed in process, finished product and stability testing (Assay, Content Uniformity, Blend Assay, Related Compound and Dissolution analysis using HPLC, UV-VIS, Dissolution System, utilizing Aligent, Chemstation, Alliance, and Millennium software, other analysis utilizing KF, FTIR and TLC

Generate data for NDA/ANDA submissions and taking part in the reviewing process.

Participated in laboratory investigations by providing scientific input to troubleshoot OOS/OOT and method deviation, Method Transfer, developing Method and Method validation.

Completed advanced Millennium training on Millennium 32 Version 4.0.

Perform performance qualification (PQ) and preventive maintenance (PM) of HPLC and Installation Qualification (IQ), operation qualification (OQ), performance qualification (PQ) of dissolution bath and fractional collector in timely fashion.

Participated actively in Pre -approval Inspection readiness audits during FDA inspection. Reviewed SOP, Method and specification and made suggestions for corrective action for final implementation.

Ivax Pharmaceutical Inc – Northvale, NJ Apr 2002 to Jun 2003

Chemist II

Performed in process and finished product testing (Dissolution, Assay, Blend Assay, Content Uniformity, Impurities and degradent, Cleaning Validations, Identification analysis using UV-VIS, HPLC, Dissolution Systems, TLC, FTIR. Utilizing Agilent, chemstation, Alliance, Millennium, and Omnic software. Performined Tapped/Bulked Density analysis, LOD, and Water content determination, using K.F.

Involved in the instrument Calibrations, maintenance, and validation. Reports data, taking part in the reviewing process, and generated data to release marketed product.

(SidMak Lab – East Hanover, NJ) Sep 2001 to Apr 2002

Chemist II

Performed Stability test (Content uniformity, Unit Spray and Full can spray Assay using HPLC, Particle Size using Malvern Laser, Microscope and Cascade Impactor)

Determined Water Content using Aqua Star C3000 Titrator, Plume test and Identification using TLC. Performed In-Process Assay using UV Spectrophotometer (using USP method), and have good knowledge about cGMP & GLP and USP.

Generated data for ANDA submissions and to release marketed product and taking part in the reviewing process.

Participated in laboratory investigations by providing scientific input to troubleshoot OOS/OOT and method deviation and Method Transfer

Scientist I, R&D (Forest Lab – Farmingdale, NY) Mar 2001 to Jul 2001

Performed Stability Test (Total assay & Degradation) and Dissolution by using HPLC.

Determined moisture by Aqua Star C 3000Titrator.

Generated data for NDA/ANDA submissions.

City College – Manhattan, NY Feb 1999 to Jul 2000

Research Assistant

Assisted the Mentor in setting up instruments and preparing solutions.

Performed Experiments using HPLC, GC-MS, Atomic-Absorption, FT-IR, Thermal Analyzer, UV and Polarography for the completion of my thesis and for the mentor's research project

Interflow technologies Inc – Flushing, NY Mar 1997 to Jan 1999

Lab Technician

Analysis of the raw materials, setting instruments, inspected finished product and assisted manager in trouble-shooting instruments.

Beximco pharmaceutical limited – Dhaka, Bangladesh Sep 1992 to Jul 1997

Assistant Manager (product promotion)

Responsibilities combined processing and writing the pharmaceutical literature to build up field forces, trained them in terms of company's policy,

Conducted feedback session with them, survey prescriptions, and analyzed competitor's activities and assisted manager in the activities which lead to the significant increase of the sales volume.

Education s

The City College of The City University of New York, NY, NY

M.S., Analytical Chemistry (2000)

Dhaka University, Dhaka, Bangladesh

M.Sc, Applied Chemistry and Chemical Technology (1990)

Personal Information k

Status: US Citizen

Publications n

Rahman H., Terrasa, J. Bandosz, A. Bagreev

Wood-Based Activated Carbons as Adsorbents of Hydrogen Sulfide: A Study of Adsorption and Water Regeneration Processes. Ind. Eng. Chem. Res. 39, 2439-2446, (2000).

Rahman H.,T. J. Bandosz, A Bagreev

Study of H2S Adsorption and Water Regeneration of Spent Coconut- Based Activated Carbon. Environ. Sci. & Tech., 34,4587-4592,(2000).

Rahman H.,T. J. Bandosz, A. Bagreev

Thermal Regeneration of Spent Coconut-Based Activated Carbon Previously used as H2S Adsorbent. Carbon 39,1319-1326 (2001).

Rahman H., T. J. Bandosz, A Bagreev

Study of Regeneration of Activated Carbons Used as Adsorbents in Water Treatment Plants. Advances in Environmental Research, in press.

Professional Affiliations b

Member : American Chemical Society, Bangladesh Chemical Biological Society of North America.

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