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Pocess developement in drug dicovery setting and quality control

Location:
Southington, CT
Posted:
April 17, 2020

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Resume:

Lila Mokraoui

adcuqp@r.postjobfree.com 860-***-****

About

4+ years of Pharmaceutical/Biotech industry experience with a diverse background in multiple disciplines such as Research, Process Development, Quality Control, Chemical Analysis, and Drug Development. Strong professional with a master’s degree of Science focused in Biomolecular Science.

WORK EXPERIENCE:

Process Development Associate I, Analytical Sciences at Alexion Pharmaceuticals, Inc. Contract Jun2019-to present

Provide analytical support to Process Development, while performing activities including formulation and stability testing for various molecules

Conduct cell-based assays in drug discovery setting and generate high quality data in timely manner.

Execute and troubleshoot Cell Based-Potency Assays (Hemolytic assay), with follow-up analysis with ELISA

Perform Weislab complement system alternative pathway (CAP) ELISA

Design and execute protein binding assays, including C5 binding Assay

Perform ELISA assay for the quantification of CHO Host Cell Proteins

Provide laboratory support services, prepare buffers, reagents and solutions

Operated various liquid handlers to aliquot various reagents

Maintain detailed and accurate records (notebook and databases) in accordance with Alexion policy.

Sample stability testing, test method validation and Technique Transfers

Data verification and Method optimization

Expertise in document management system, TrackWise, FirstDoc and SharePoint

Experience with various MS Office programs, including Word, Excel, Outlook, and PowerPoint

Experience with Molecular Devices including SpectraMAx Pro and Softmax Pro Gxp

Carla’s Pasta, South Windsor, CT August 2018-2019

Quality Assurance Technician

Execute analytical work to ensure compliance with cGMP, SOP and followed the Good

Documentation Practices (GDP).

Monitor and execution of QA programs. Physically and visually verifying and monitoring protocols and programs.

Physical monitor and verify that product specifications are being met particularly in terms of Food Safety Quality.

Perform pre-operational sanitation checks. Maintains high level of sanitation awareness and implement corrective actions in situations that warrant

Conduct research on Quality Assurance issues and deliver reports on research to management.

Maintain ongoing company compliance with all applicable regulations and 3rd party auditor requirements. Performs Hazard Analyses Critical Control Point (HACCP) monitoring. Ensures USDA, FDA label compliance

Receive and verify ongoing certificates of analyses and specifications

Sample collection and testing: Maintain data and submit samples for extensive microbiological testing. Execute sample collection and submittals to external laboratory vendor for batch testing

Calibrate equipment used in verification of production and quality assurance

Conduct laboratory work using thermometers, scales, micrometers, metal detectors, X-ray machines, rheometer, salt analyzer, color spectrometer, sanitizer solutions and dispensers

Perform sensory evaluation checks on batch ingredients, cooked product pre-packing checks, new products and as required, examines products for viscosity, elasticity, salt levels, Texture of product, micrometer measurements of pasta thickness and uniformity of product

Provide independent oversight of process, verifying compliance to company standards and policies, and effectively communicating when there are deviations from standards or processes

Assist in training employees on food safety, company processes and FDA Good Manufacturing Practices

Perform a good Aseptic Technique

Execute swabs and submittals to external laboratory

Central Connecticut State University, New Britain, CT September 2015-2018

Department of Biomolecular Sciences

Independent Research Projects

Analysis of Escherichia-coli mutants that cannot maintain the F-plasmid.

Advised and assisted several students, including undergraduate researcher.

Cedar Enterprise Southington, CT August 2008 - June 2017

Quality Supervisor

Supervising food quality and monitoring the food safety.

Managing and training team member regarding food safety.

Town Hall of the Municipality of Algeria June 2005 – June 2008

Employed as state registered inspector in Biology

Controlling public food safety

Central Hospital University of Algeria 2000 - 2004

Research Assistant

Department of Biology

Collaborated across labs to identify a novel bacterial cell cycle checkpoint.

Investigated the physiological changes of starving bacterial cells.

Developed a cell synchronization protocol for the replication of Escherichia coli cells.

Education:

Central Connecticut State University, New Britain, CT September2015-May 2018

Master of Arts “Biomolecular Sciences”

Tunxis community College Farmington CT Jannuary2012 -May 2012

Certified Pharmacy Technician CPhT

University of Algeria September-1999 July 2004

Engineering Degree in Biology with specialization in Quality Control and Analysis

Algerian Honors Thesis July 2003-July 2004 Isolation and identification of potentially toxigenic mold that can contaminate the wheat. Perform a dosage of Ochratoxin A in Aspergillus ochraceous.



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