Quality Control Raw Materials

MOHAMMED M. RAHMAN

RESUME

PERSONAL DATA

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SUMMARY

-20+ years of analytical chemistry experience in quality control and research and development laboratories.

-Knowledgeable of industry regulatory requirements, including FDA, cGMP, GXP, OSHA, ICH and CAPA process & CFR part-111.

-Able to design, plan & execute laboratory experiments to evaluate system performance.

-Expertise in instrument calibration and preventive maintenance, development and validation of analytical methods and processes, stability testing and laboratory instrumentation records maintenance.

-Adept at adapting diverse knowledge and experience to any situation while ensuring a high level of quality and compliance and familiarity with instrument manufacturing processes as a prototype software and data collection tools (HPLC/GC Software integration).

-Knowledgeable about validation/process validation.

PROFESSIONAL EXPERIENCE

KEBCO Pharmaceutical: October 2017 Present :: Start a new job in QC as a Technical senior Scientist. Analysis of Raw material, finish product using, HPLC UPLC, UV-VIS, ICP_OES.(Perkin Elmer) for elemental Analysis.ICP-MS,Elan-9000 for Heavy Metal Test. Analytical testing of method Validation, Method development of dietary products. Analyzing dietary supplement, in accordance with GMP & GLP, CFR-part-111.Developing their Instruments calibration SOP. Execute & Monitor Stability Study as per ICH guide line & Inventory maintain of all reagents used in lab & orders if necessary. For sample analysis Using GC-HS, GC-MS, FTIR, & Dissolution. Fluoride Test, Acid insoluble, Total Ash, according to USP Monograph.

Analytical/R&D Senior Scientist

Dec. 2012 – Jun. 2017

ALTAIRE Pharmaceutical Inc.

Aquebogue, NY

-QC & R&D- testing of the following: Raw materials, packaging components, in process sampling, process characterization samples, cleaning verification samples, stability samples, water samples, formulation development samples, process validation samples, R&D development samples, Method validation, Development on PEG-400 by UPLC & Benzalkonium Chloride C12-C14-C16 separation by H-UPLC in drug discovery team.

-Formulation and Evaluation solid & liquid dosage forms (UV-Vis Osmolality, Surface tension, Kinematic viscosity, Particulate matters, weight loss, leak test of ointment.

-Assays of EDTA. Titration of glycerin, Assay of CMC 7LF. Assay of Tobramycin Ophthalmic solution, Polyhexanide & Poloxamar 407, Phenylephrine HCL, Of Polyvinyl Alcohol 0.5% Povidone 0.6% Tetrahydrozoline 0.5% Ophthalmic Solution

-Extractable & Leachable Analysis on a different Ophthalmic Product, Assay on Timolol Maleate & Dorzolamide HCL, Assay on Fluorexon disodium & Benoxinate HCL Injection, Assay Of Ofloxacin HCL & Assay of Ciprofioxacin HCL 3mg/ml.

-Method validation of PEG -400 & Propylene Glycol (Recovery, Assay precision, Linearity, Sensitivity, Intermediate Precision.

-cGMP Stability Analysis on Lubricant eye drop & different OTC Products. Utilized Chromatographic Purity, Degradation studies, Chiral Analysis with HPLC 2.5% &10%.

-Analysis on Polymyxin B So4 Bacitracin Zinc, Neomycin SO4 ophthalmic ointment, Vetropolycin HC ointment (NDA). Hyland Earache Drops, Homeopathic Earache Drops, Ringing Relief Ear drops. Bacitracin ophthalmic Oint, Erythromycin OPH Oint, Gentamycin SO4 Ophthalmic solution, Murine Tears plus, Lubricant Redness Reliever Drops, Tetra Caine HCL, Benzyl Peroxide & Hydrocortisone Acetate 1%, 0.5% Lidocain Ophthalmic Solution. Particle distribution (PSD) & Next Generation Impactors experiences.

Research Chemist II Aug. 2011 – Oct. 2012

SUN Pharmaceutical Industries Ltd.

Cranbury, New Jersey

-QC/R&D/Stability: Analyzed finished products via blend uniformity, Stratified CU, Assay/CU, ID-A/B/C. Most analyses were run on Waters UPLC/HPLC 2695/2487/PDA/2489.

-Most actively working with Process validation team where I analyzed large samples on variable release marketed products. Head trouble shooter of all QC HPLC

-Conducted cGMP Stability Analysis

-Analyzing impurity testing on OTFC, Morphine Sulfate, and Methylphenidate ER & Open able Layer, Oxycodone, Promethazine, Verapamil, HCB/APAP, Benzoate Capsule/ Tablets

-Stratified in-process dosage unit samples to demonstrate acceptable content uniformity for batches at the beginning, middle & End of runs

-Conducted Compression runs on LHS/RHS on different Tablets strengths. Also, conducted data integrations, instrumentation methods, processing methods, utilized Empower-2 for Method sets, custom Calculation.

-Tested DEA Product Examples: Oxycodone/HCB/ Morphine Sulfate, etc. Performed Cleaning Validation in QC with STD CIP-100. (Detergent). Also tested R&D Method Transfer Samples to validate the methods for QC .

Scientist II/ Metrologist II Mar. 2001 – Dec. 2010

TEVA/Barr Pharmaceutical Industries Ltd.

Cranbury, New Jersey

-Analyzed raw materials and finished products, including stability and formulation support testing, and completed process validation testing

-Monitored analytical method transfer activity between analytical research and the quality control laboratory

-Aided in the development, validation and analytical analysis of active pharmaceutical ingredients and other drug products in compliance with GMP protocols and support of FDA guidelines

-Wrote protocols, comparative reports, test methods, validation reports, method transfer and deviation reports and accurately maintained all laboratory records and chromatograms. Was trained in SAP implementation

-Utilized UPLC/ RRLC equipment and chromatographic parameters, including column technology, mobile phase, flow rate and temperature, to create faster and more robust RRLC/ H-UPLC testing methods

-Provided technical support in out-of-specification investigations and trained new employees on technical specifications, standard operating procedures and cGMP and safety requirements.

-Reviewed and designed instrument qualification (design, installation, operational and performance qualification) and calibration protocol as per current industry requirements

-Calibrated UPLC, HPLC, RRLC -1200, 1100(Agilent) Trouble Shooter of 99% of All LC System in R&D Labs.

-Developed a testing method for active pharmaceutical ingredients and finished products, including polyunsaturated fatty acids (omega-3).

-Organized and developed a complete inventory database of standard room temperature products

In-Process Validation Team Scientist/ Instrumentation Scientist II Feb.1997 – Mar. 2001

NOVARTIS Pharmaceutical Corporation

Suffern, New York

As the In-Process Validation Team Scientist at the Satellite QC Process Validation Laboratory/ Novel Drug Delivery System Laboratory

-Supplied computerized process optimized data in order to validate a new manufacturing facility for FDA, ANDA & NDA submission.

-Performed assay, unit dosage and final blend analysis on capsules and tablets, including testing for content uniformity, impurities and dissolution testing utilizing HPLC and UV/VIS methods

-Tested finished products for batch release according to established quality standards

-Assisted with the development of a transdermal and topical therapeutic system meter dose inhaler technology and respiratory drug delivery system using many laboratory techniques. Working on metered dose inhalers & Nebulizers solution,(Albuterol solution)

As the Instrumentation Scientist II

-Calibrated, maintained and diagnosed problems with and performed repairs on numerous pieces of laboratory equipment.

-Completed instrumental installation, operational and performance qualification testing on all equipment

Mar. 1995 – Dec. 1997

Analytical Chemist III SANDOZ Pharmaceutical (Previously EON Labs)

Long Island, New York

-Assayed finished products, raw materials, intermediate, blend and process validation samples in conjunction with the quality control and auditing departments and as a calibration chemist.

-Prepared and standardized necessary testing solutions and performed cleaning validation analysis.

-Supported the applied research and development department with method development to expedite product release for submission to the FDA.

Analytical Chemist II Jun. 1994 – Mar. 1995

Graham Chemical and MiniMax Company

Long Island, New York

-Analyzed samples in all stages of the pharmaceuticals manufacturing process following USP/NF, Supplemental USP, GLP and other standards precisely. Tested all kind of Dental Products and Skin.

-Created solution for a problematic composite assay for parental dosage forms.

-Designed a concept for the validation of the water for injection system and submitted a waste water test report for production and to the EPA.

Senior Chemist Mar. 1989 – Dec. 1994

Blue Cross Products (Previously Halsey Drug Co.)

Long Island, New York

-Provided qualitative and quantitative quality control analysis on pharmaceutical raw materials.

-Completed quality testing on in-process, process validation and QC release samples, specializing in the analysis of solid, semi-solid and oral liquid dosage forms.

-Performed in vitro dissolution studies on solid dosage forms of generic pharmaceuticals.

-Collaborated with the method transfer team to perform analytical testing on new medications.

-Created and maintained a stability program for monitoring and storing retainer samples.

-Utilized the HPLC gradient method in order to assay impurity degradation.

EDUCATION & TRAINING

Post-Graduate Instrumental Method of Analysis and Separation of Media HPLC. UPLC; Long Island University, Brookville, NY

M.Sc. Chemistry, University of Dhaka, Nilkhet, Dhaka, Bangladesh

B.Sc. (Hons) Chemistry, University of Dhaka, Nilkhet, Dhaka, Bangladesh

Instrumentation and Equipment:

-Instrumentation:

HPLC, component LC, PDA, refract meter, fluorescence detector, UPLC, H-UPLC, Acquity UPLC, SQ mass spectrometer, RRLC, LC/MS, KF, polarimeter, TLC, bio- disc apparatus, UV-VIS, photodiode array spectrophotometer, FTIR/IR, melting point apparatus, dissolution USP apparatus1 and 2, automated Zymark dissolution workstation, online automated Distek, robotic dissolution system, satin box for HPLC and GC, viscometer, disintegration tester, hardness tester and pH meter, Osmolality, Kinematic Viscometer test

-Equipment:

Fraction collector, furnace, chart recorder, vacuum gauge, vacuum oven, air sampler, heat sealer, tablet counter, friabilator, Tablet Processing Workstation 11

Computer Software:

-Microsoft Word, Excel and PowerPoint, PALAS

-LIMS, Novartis WNEWS NT, GX Parma, SAP, WISDOM, Millennium 32

-Empower 1, Empower 2 & 3

-Total Chrome and Chem Station.

Additional Training & Certifications:

Completed qualification training in the use of laboratory instruments, including:

-Waters Alliance 2695 and 2690 HPL

-Component 717, 510 and 600 HPLC

-Agilent 1100 and 1200 HPLC

-HPLC run by Empower-1,2 and 3

-Gradient proportion valve calibration in HPLC and UPLC and the calibration of PQ of refractive index and fluorescence detectors, Novartis/Barr Labs

-Waters: Alliance Operation and Performance Maintenance Training, Barr Labs

-Waters: Troubleshooting and Performance Maintenance, Barr Labs

-Alpha Tech: HP 5890 Gas Chromatograph Troubleshooting and Maintenance, Novartis

-Blue Mountain’s Crystal Reports for Calibration Manager Software Certification, Novartis

-OSHA Standards Training-Electrical Low & High Voltage Safety Training, Novartis

-Waters: Strategies to Faster HPLC Method Development, Novartis

-Execu Train Computer Novartis Parma Requirement Training, Novartis

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