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Quality Control Development

Location:
Boston, MA
Posted:
December 08, 2014

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Resume:

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** ******* ******, *** #*

Amina Soukrati, PhD Somerville, MA - 02144

Tel: 617-***-****;514-***-****

*************@*******.**

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Amina Soukrati

Summary

Scientist with broad research experience in analytical chemistry, reformulation of existing drug, preformulation, formulation

and drug quality control, small and pilot scale development, analytical method development and validation

Experienced with instrumentation and techniques ( DSC, DLS, LD, SEM, HPLC, TLC, GC, LC-MS, UV-Vis / Fluorescence

Spectroscopy, IR and Raman Spectroscopy) for characterization and quantitation of drug product during production process

Proficient in the design, development and validation of HPLC analytical methods using different detectors

( fluorescent, electrochemical, UV-Vis and evaporative detector (ELSD))

Highly experienced in dissolution study, drug release, thermal stability testing and forced degradation study for developed

drug formulation

Efficient in synthesis and physicochemical characterization of drug nanosuspension and material polymer (hydrogel and

microbeads polymer)

Implemented methods that meet FDA requirements, cGMP/GLP expectations and ICH guidance for new pharmaceutical

formulation

Demonstrated high knowledge in solid chemistry, physical chemistry, polymer chemistry, electrochemistry, physical pharmacy

Expert in liquid and solid dosage forms formulation development

proficient in written and verbal communication skills; Self motivated, able to work independently and collaboratively ; Strong

project management skills, including the ability to prioritize, organize, to multi_task and to meet the projects timelines; Strong

ability to seek knowledge in a specific research area

Fluently bilingual in French and English and easily integrated into team environments

Experience

Analytical development/Quality Control (Contractor) Jan 14 – June 14

Boston Analytical, Salem, NH

Performed HPLC analytical method development, validations and method transfers for client and USP based methodologies

Wrote validation and method transfer protocols and reports in accordance with ICH USP guidelines

proceeded data analysis and management using LIMS

Executed method verification and validation compliance to SOP and specification

Wrote technical report related to assigned work in an electronic notebook

Ensured that all work performed is performed in compliance with standard operating procedures, good manufacturing

practices, and the regulations of the Food and Drug Administration

Participated in reviewing documentation, and documented work in a clear and organized manner

Conferred with other chemist and client personnel regarding research, procedures performed and related results and prepared

reports

Conducted testing of raw materials and components, in process and finished product sample in compliance with SOPs, GMP,

and FDA regulations

Developed quantitative HPLC method for dosing solutions

Identified and implemented methods for cost savings, improved efficiency and control

Research Scientist Oct 09 – Mar 13

M.S. in Pharmaceutical Sciences (Pharmaceutical Technology)

Faculty of Pharmacy, Université de Montréal, Montreal, Canada

Developed new oral liquid dosage formulation from solid dosage form (Prevacid Fast Tablet) of Lansoprazole

Evaluated chemical stability, degradation study, dissolution and content uniformity of Lansoprazole

Developed and validated an analytical HPLC method for Lansoprazole detection

Developed and validated an analytical HPLC method with ELSD detector (evaporative detector) for

1-docosanol detection in standard solutions and in nanoformulations samples

• Prepared and pilot scale processing of new formulation based on docosanol nanosuspension

• Prepared and characterized a docosanol semi solid dosage form (gel) based-nanosuspension for topical use

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Amina Soukrati

Evaluated the docosanol degradation study in nanosuspension and its stability in gel form at different temperature

Characterized docosanol nanosuspension and gel by DLS and LD for nanoparticles size measurement, by DSC for crystalline state

study, by SEM for morphology study, by Brookfield Viscosimeter for rheological studies and by Franz Cell for the in Vitro drug

(docosanol) release study from prepared gel and commercial product (cream) through a polycarbonate membrane fixed in Franz-

cell

Research Scientist Jan 09 – Sep 09

Massachusetts College of Pharmacy, Boston, MA

Studied Indomethacin crystallization and characterized its crystals by Raman Spectroscopy, Infrared Spectroscopy and differential

scanning calorimetry (DSC)Spectroscopy

Quantified alpha and gamma crystalline form of Indomethacin by Raman spectroscopy

Determined the pH effect on drug solubility process

Evaluated Indomethacin precipitation inhibition by polymer PVP-90

Evaluated of some solid dosage form tablets by studying: hardness, friability, weight variation, disintegration and dissolution

Postdoctoral Research Fellow May 05 – Dec

07

Northeastern University, Boston MA

Performed radiochemical synthesis and HPLC purification of radiotracer such as agonist and antagonist of CB1, CB2 cannabinoid

receptors

Quantified the level of radio-labeled compounds (3H or 125I) in radiotracers

Performed tail intravenous injection and peritoneal injection of radiotracer to mice followed by dissection/ micro dissections of

mouse brain and organs

Worked with radiotracer to determine drug metabolism and the uptake of its drug in different 5 regions of the brain, in blood and in

nine different organs of mice

Designed, developed and validated an analytical method for Glutathione detection in Biological cells using HPLC with

fluorescence detection and mass spectroscopy

Performed micro-dissection of rat brain

Did protein assay for quantification of proteins in rat brain

Developed and validated an analytical HPLC method with electrochemical detector for catecholamine’s detection (such as

dopamine and norepinephrine) in rat brain

Analytical Chemist Jan 04 – Apr 05

Acti Lab Pharma, Montreal, Canada

Performed analytical chemistry assays based on new and existing methodologies, operated analytical instrumentation such as

HPLC, GC, and LC/ MS

• Provided technical report with interpretation of test results

• Developed, established, and validated analytical testing methodology used to control raw materials, production intermediates, and

final products in cosmetic and pharmaceutical field

Teaching Assistant Jan 02 – Dec 03

Department of Chemistry, Université Libre de Bruxelles, Brussels, Belgium

Prepared syllabus, designed experiments, taught prelab and lead a group of 20 undergraduate and graduate students in lab classes

for analytical chemistry laboratory and material polymer chemistry laboratory

• Mentored and guided a group of 30 undergraduate students for general chemistry laboratory class

• Lead section meeting and tutored students in lectured classes for general chemistry, analytical chemistry and macromolecular

chemistry

Graduate student; PhD Candidate Jan 97 – May 01

Macromolecular Chemistry Laboratory/ Department of Chemistry

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Amina Soukrati

Université Libre de Bruxelles, Brussels, Belgium

Dissertation topic: Photochemistry, Photophysics and Enzyme Immobilization in Hydrogels

Synthesized and studied properties of ionic and nonionic hydrogels based Polymers

Studied controlled free radical polymerization of acrylamide monomer crosslinked by methylene bis’ acrylamide for hydrogels

membrane which is initiated by three different methods: using thermally decomposable initiators

(sodium persulfate Na2S2O8), photoinitiators like sodium anthraquinone sulfonate or gamma radiation

Synthesized hydrogels in membrane shape or microbeads form

Developed an enzyme biosensor by immobilization of glucose oxydase in hydrogel microbeads

Developed a reused heterogeneous photosensitizer and photocatalyst by ionic exchange fixation in cationic hydrogel

Studied hydrogel microenvironment by fixation of fluorescent probe

Graduate student: Master study Sep 95 – Nov 96

Bioelectrochemistry& instrumental analysis laboratory, Pharmacy Institute

Université Libre de Bruxelles, Brussels, Belgium

Dissertation topic: Amperometric detection of hydrogen peroxide on gold electrode

Studied the electrochemical behavior of hydrogen peroxide at modified and non modified gold electrode

Proceeded to a platinum layer deposit on gold electrode after its modification for hydrogen peroxide detection in interference of

ascorbic acid

Education

Master in Pharmaceutical Sciences, Université de Montréal, Montreal, Canada, 2009-2013

PhD Sciences; Chemistry, Université Libre de Bruxelles, Brussels, Belgium 1997-2001

Master of Sciences in Applied Chemistry (Hons.), Université Libre de Bruxelles, Brussels,

Belgium, 1995-1996

• Bachelor of Sciences; Chemistry, Université Chouaïb Doukali, El Jadida, Morocco 1993

Scientific guest lectures and Publications

Development and characterization of a docosanol nanosuspension and a semi solid topical formulation for HSV viral treatment (in

preparation for patent work and publications 2014-2015). A.Soukrati and Grégoire Leclair.

• Quality evaluation of extemporaneous delayed-release liquid formulations of lansoprazole. American Journal of health-system

pharmacy, 2011 Nov 1: 68 (21): 2069-74. A. Melkoumov, A.Soukrati & al.

• Evaluation of the in vivo receptors occupancy using radiolabeled agonist and antagonist of cannabinoid receptors (in

preparation for patent work). S.John Gatley and A.Soukrati.

• Re-examination of the dopamine hypothesis concerning longterm neurological effects of HZE radiation ( Grant report ) S.John

Gatley, A. Soukrati and al.

• Fabrication of specify glucose electrode by enzyme immobilization in hydrogels. A.Soukrati. Electrochemistry journeys 01,

Marrakech, Morocco.

• Investigation of polyacrylamide hydrogels using 1-anilinonaphtalene 8-sulfonate (ANS) as fluorescent probe: 2000. G.

Geuskens and A. Soukrati. European polymer journal 36, 1537-1546.

• Photochemistry and photophysics in hydrogels: May 1999. A. Soukrati. Belgian polymer group.

• Amperometric detection of H2O2 on gold electrode: 1996. Soukrati. M.Sc. Dissertation, Université Libre de Bruxelles,

Belgium.

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Amina Soukrati



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