Mahin Nouri

San Diego, CA ***** Phone (H): 858-***-****

E-Mail: adyyle@r.postjobfree.com Phone (C): 858-***-****

Summary

Highly motivated, team oriented, and enthusiastic Analytical Chemist/Clinical Lab Toxicology Scientist with broad knowledge and experience in bench top chemistry, GCP, GMP/GLP, QC process, data analysis & review, LC-MS instrumentation, and trouble shooting. Experienced in writing SOPs, technical guidelines, and analytical/validation reports. Expert on LIS and Exemplar software.

Analyzing and reporting laboratory test results for all test methods developed for LCMS runs

Writing technical documents, SOPs, training new staff and reviewing their competencies, validation studies

Quality control and process development based on QSR, GMP, GLP, and ISO 9001 regulations

Gauge R&R and stability studies, data entry, statistical calculations, and creating QC charts

Creating calibration curves, trouble shooting, & risk assessments

HPLC /LCMS method development, validations, and instrumentation

MassHunter & ThermoFisher LCMS quantitative data analysis. Review and interpretation of complex analytical problems, optimization, and tech transfer

WORK EXPERIENCE

Exagen AVISE, (Vista, CA) Dec 2020-Current

Clinical Laboratory Scientist II/Technical Supervisor –Toxicology /LCMS Department

Responsible for blood compound extraction process, Immunosuppressant drug assay preparation, LCMS run of whole blood and RBC samples from the patients taking prescription drugs for Lupus and Rheumatoid Arthritis, at CLIA regulated laboratory. Analysis, review, and releasing the final results on Exemplar software.

Making Standard and QC reagents, processing whole blood, washing RBCs, using UV-VIS spectrophotometer and running them on ThermoFisher LCMS/MS instrument, and their characterization/qualification. Accomplished creating stability test for multiple compounds to save 50% of their cost and preparation time.

Performing Alternate Proficiency tests, competency panels, and column qualification using LCMS-MS technology, validating new methods

Instrumentation on ThermoFisher including, cleaning ITT source, maintaining the pumps, preparing mobile phases, etc.

Technical supervisor and lab management including reviewing and up-dating SOPs, QC logs, creating IQE on MediaLab for Events that need CAPA and for Data Logs.

Accomplished changing manual data entry to automated process in collaboration with IT support engineers. Optimization on acidic extraction method and cost savings.

Millennium Health Laboratories, (San Diego, CA) Dec 2010-Dec 2020

Clinical Laboratory Scientist I – Data Analysis and Review (DAR) Nov.2015-Dec. 2020

Responsible for testing and reporting laboratory test results for all test methods approved by CAP and CLIA including pain medications, cannabis, alcohol metabolite, and synthetic illicit compounds according to GMP regulations.

Validated new assay and LCMS method for Fentanyl Analogue panels and supporting R&D department on their different projects

Accomplished to up-grade the filing system for multiple projects and save 10% cost on hard copies and storage space. Improved documentation process on main checklists for CLSs.

Trained Associate Scientists and CLSs on creating calibration curves, data analyzing and review, and trouble shooting. Processed their annual competencies. Reviewed and corrected technical SOPs for DAR department. Collaborated with QC and LCMS department on maintaining Quality Control of standard reagents and assay preparation.

Instrument Maintenance Specialist/ Associate Scientist I/ II Dec. 2010-Nov. 2015

Analyzed and processed liquid chromatography data of urine/oral fluid samples processed on “Agilent LCMS MassHunter Quantitative” and “ThermoFisher” instruments in a high throughput clinical laboratory according to GMP regulations.

Responsible for maintaining the operation of LC-MS/MS instruments; troubleshooting problems and resolving the issues including auto-tune calibration, column change, fixing pump valves and capillary connections, and other related LC parts.

Accomplished creating multiple guidelines and manuscripts, in addition to training

Instrument Specialists in order to increase the consistency of operation process among team members.

NextPharma BioServ (San Diego, CA)

Production Chemist II, July 2010-Dec. 2010

Processed pharmaceutical assay and compound reagents, medical device solutions, and buffers. The process included formulation, pH titration, and filtration through aseptic techniques.

Created Batch History Records (BHR) and reviewed them along their adjacent documents. Performed BOM transactions. Inspections and audits in collaboration with QA process.

Performed calibration of lab instruments, quality control of raw materials and finished products, and quality assurance of the formulation process according to GMP/GLP process.

Accomplished up-grading many lab equipment and improved large scale formulation process.

Gen-Probe Incorporated, OTS Department (San Diego, CA)

Process Development Associate II (Temp. Position), Feb. 2010-June 2010

Processed target capture, amplification, and enzyme assay reagents, buffers, and calibration solutions at clean room laboratories and through aseptic techniques. The process included reagent formulation, spiking with oligonucleotides, aseptic filling, lyophilization, and labeling.

Performed documentation for development and manufacturing process-orders, based on GMP requirements, including sampling frequencies and quality control of the product.

Performed SAP and MRP transactions, documentation reviews, and investigation on source of discrepancies for supporting QA department.

Responsible for daily and weekly laboratory audits. Improved calibration process for portable lab tools in regards to their metrology calibration, quality control, and GMP documentation. Created metrology calibration file on the team’s SharePoint in order to achieve more accurate calibration process.

Pfizer Pharmaceutical Inc, Medicinal Chemistry Department (San Diego, CA)

Research Associate (Contract Position), April 2009-Jan. 2010

Maintained Agilent ChemStation HPLC and LCMS instruments, performed and analyzed chemical characterization

Performed purification process on Agilent prep HPLC units and created recovery tests using Roto-evaporator and Lyophilizer (Freeze Drier) in order to monitor instrument performance.

Performed Photo-stability tests using UV light chamber, spectrophotometer, and LCMS instruments in order to calculate percent of degradation on prototype samples.

Developed new LCMS purity method using more efficient commercial columns to improve the peak resolution.

Accomplished a better logging system by creating an electronic Log-Book on all sixteen LCMS and HPLC units at Medicinal Department to improve documentation of different tasks in regards to instrumentation, calibration, and maintenance. Laboratory inspections and audits for any deviation from GLP/GMP regulations.

Hewlett-Packard Company, R&D Department (San Diego, CA)

Lab Technician III, Chemical Formulation Laboratories March 2004– Dec 2008

Formulated chemical reagents and experimental samples, qualified the prototype and final candidates by characterizing their physical and chemical properties including: % solids, density, pH, viscosity, surface tension, electric conductivity, particle sizing (AccuSizer & Nanotrac), UV-VIS spectrophotometer, and their accelerated shelf life data.

Responsible for maintaining laboratory instruments through calibration, trouble shooting, and communications with manufacturing vendors. Led R&R gauge studies on particle sizing instruments and quality control of prototype samples.

Created six different manuscripts, SOPs, and certification documents for new laboratory instruments. Trained and certified all the laboratory team members on running particle sizing units and other critical tasks.

Held the chemical representative position for IFL team for more than three years. Created and up-dated inventory lists and log out sheets for process improvement.

EDUCATION AND TRAINING

Master of Science in Food Science and Technology San Jose State University, San Jose, California

Areas of concentration: lipid, peptide, and carbohydrate chemistry, biochemistry, food microbiology, product development and process engineering, quality control, and statistics.

Bachelor of Science Institute of Nutritional Sciences and Food Industries, University of Medical Science, Tehran

Areas of concentration: General Chemistry, Biology, Food Microbiology & Toxicology.

CERTIFICATIONS

California Clinical Toxicology Scientist, Lic#; MTF-01000139

National Registry of Clinical Chemists (NRCC) Certificate,Reg#; 4146

Certified Bio-technician

Nevada Certified Specialty Technologist (Chemistry/ Toxicology) Lic#; 29628 TS-3

Passed ASCP Clinical Chemistry Exam

Volunteering Work; BBBS (Big Brother Big Sister) of San Diego,

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