Project Management Assay Development

Bioanalytical Scientist

A Bioanalytical Scientist with over ten years of experience in Pharma/Biotech Research and Development and Analytical/QC departments. Recognized for expertise in Biochemistry, Molecular and Cell biology, Immunology, Virology, and Protein biology. A strong team player with excellent oral and written communication skills with ability to work independently. Excellent critical thinking skills developed through the review and publication of numerous scientific publications and pharmaceutical documents and presenting in conferences. A resourceful problem-solver and motivational leader who coaches and develops high-performing teams.

Biological Assay Development and Method Transfer Assay Optimization and Improvement Method Validation, Verification and Qualification Analytical Methodologies and Analysis Method Review, Documentation and Assessment Bioanalytical GxP Laboratory Team and Project Management Quality Management System Electronic GxP Documentation Systems: Veeva, GEODE, Trackwise, LIMS

TECHNICAL SKILLS

Cell biology: Cell culture and Cell-Based assays, Stable Cell lines, BSL2, Cell-counting, Cell isolation, Cell Transfection and Transduction, Sterility, Mycoplasma.

Biochemistry: ELISA, Western Blot, Gel Electrophoresis, SDS-PAGE, Recombinant protein expression, Cesium Chloride (CsCl) gradient separation and purification using dialysis and chromatographic techniques.

Immunology: ELISA and potency assay development, immunoassays, flow cytometry, Immunocytochemistry, antibodies, antibody drug conjugates, peptide-based therapies, dot blot.

Microscopy: Electron microscopy including Transmission Electron Microscopy (TEM), Scanning Electron Microscopy (SEM), Immunogold TEM, Immunofluorescence, Confocal Microscopy, Histopathology Leica Microscope, Industrial Microscopy, and Phase Contrast Microscopy.

Virology and Microbiology: Virus, bacteria and yeast culture, differentiation, fermentation, CFUs analysis, generating glycerol stocks, lysis, vaccine development.

Molecular Biology: PCR, qPCR, ddPCR, RT-PCR, DNA/RNA/protein assays, DNA Sequencing, Gene Cloning, reporter gene, Plasmid extraction, restriction digest analysis, Agarose Gel Electrophoresis, Cell Line Genetic Characterization Techniques.

Analytical instruments: pH, Osmometer, Particle Size Enumeration and Protein structure by FT-IR methodologies, familiar with HPLC and GC.

Bioinformatics: R and Expression Console, QPCR analysis software, ddPCR analysis software, Primer design software, Primer3, MEGA6, Gene runner, Chromas, and microscopic image analysis.

Computer skills: Laboratory Information Management System (LIMS), Microsoft Office including Word, Excel, PowerPoint and Outlook, TrackWise, Phenix, GEODE, Veeva, SoftMax Pro and PLA3.

PROFESSIONAL EXPERIENCE

Minaris Regenerative Medicine, Allendale, NJ, United States August 2023 – Jan 2024

Analytical QC Supervisor (contract position)

Oversaw the Quality Control Tests for Gene and Cell Therapy including Sickle Cell Anemia and CAR-T Cell Therapy and managed 8 lab analysts (direct reports).

Scheduled, led and executed Flow Cytometry, Cell Biology and Hematology tests on the cell therapy products.

Managed projects and led initiatives in the workplace, initiated and led Change Controls and Deviations.

Improved quality control, lab management, and bookkeeping in accordance with the GMP.

Reviewed and approved QC documents using electronic documentation systems (Veeva)

Collected, sorted and processed cell samples, performed analysis, and presented the results to peers and supervisory management.

Sanofi Pasteur, Toronto, ON, Canada May 2021 – March 2023

Scientist, QC Analytical Excellence Department

Oversaw/ led Immunochemistry, Cell Biology and Animal Test Methods improvement and troubleshooting by analytical methodologies and data analysis.

Led, designed and executed method optimizations, improvements, qualification, validation, and transfer of assays to a GxP or regulated laboratory environment listed in ICH Q2 and USP<1033>, and EP and CFR guidelines and regulations.

Led ALCM method assessment periodic review and addressed method validation gaps.

Authored validation protocols, reports, investigation protocols, and SOPs using electronic documentation systems (GEODE).

Launched and led Test Method Development and Transfer, Validation, and Qualification.

Initiated, reviewed and approved change control, deviation, and investigation in the Electronic Quality Managements system, Phenix.

Reviewed and approved SOPs, protocols, reports, and other QC-related documents using electronic documentation systems (GEODE).

Led assay development by revalidation and qualification of in-process and impurity-related residual.

Directed, scheduled, and approved Immunochemistry and Cell-based assays test results.

Led and delivered project objectives under aggressive timelines within a dynamic environment.

Trended and tracked Data using Statistical Process Control software (SPC).

Collaborated with RA team in regulatory filings (IND and BLA) and external scientific publications and reviewing internal technical reports.

Performed GEMBA walks and lab walkthrough, created and reviewed Deviations, Change Controls, OOS, OOT, and CAPA.

Actively contributed to cross-functional meetings and represented analytical functional area to team.

Improved Quality Operation of the team for GMP audit, FDA, and Health Canada site inspection.

SGS, North America, Mississauga, ON, Canada August 2019 – April 2021

Scientist, QC Analytical Cell Biology Department

Led and executed test development, feasibility, verification, validation, and qualification study to develop new test methods.

Assessed Cell-Based ELISA and Potency Bioassays by SoftMax Pro and Parallel Line Analysis (PLA3).

Initiated, reviewed, and approved tasks in TrackWise for change control, deviation, investigation, and root cause analysis (RCA).

Improved GMP QC testing and professionally communicated with project managers and clients.

Handled LIMS for lab requirements and tracked the workflows in a step-by-step process.

Prepared and published Feasibility, Verification, Validation, and Qualification Reports, Investigation and Technical Reports, Test Methods, Protocols, and Worksheets.

University Health Network (UHN), University of Toronto, ON, Canada September 2014 –March 2017

Postdoctoral Scientist, Physiology Department, Wheeler’s lab

Executed Immunological assays including single-plex and multiplex immunochemistry (ICC and IHC) and ELISA, cell and molecular biology including qPCR and ddPCR resulting in establishing the worldwide shortest time for differentiation of human stem cells to pancreatic beta cells.

Assessed GABA in mouse and human pancreatic cell lines and islets, resulting in converting of pancreas function by regeneration of beta cells.

Authored, analyzed, reviewed and published papers with detailed results for impact of GABA on pancreatic islets and, for differentiation of human stem cells to pancreatic beta cells.

Equipped and organized molecular analytical biology lab and trained five (5) master students.

Contributed to proposal writing, resulting in bringing two grants for lab from OIRM and CIHR.

National Reference Center for Enteric Viruses, CHU Hospital, Dijon, France December 2010– November 2012

Research Scientist, Virology Department

Led an international liaison for studying the prevalence of Enteric Viruses in Calves.

Achieved a trend for prevalence of the bovine Rotaviruses and published the first international report on the area of study.

Determined and reported a new trend for Molecular Epidemiology of Caliciviruses and Noroviruses by scrutinized analytical study.

Authored, reviewed and published papers with detailed results and analyses on new trend.

EDUCATION

Project Management School of Continuing Studies, University of Toronto, Canada 2018 - 2020

Postdoctoral Fellow Physiology Department, University of Toronto, Canada 2014 - 2017

Ph.D. in Biochemistry Institute of Biochemistry & Biophysics, University of Tehran, Iran 2001 - 2007

(Thesis: Cloning and expression of a human rotavirus VP2 gene and detection of its immunogenicity in mice using intranasal administration)

M.Sc. in Biochemistry Institute of Biochemistry & Biophysics, University of Tehran, Iran 1998 – 2001

(Thesis: Transcribing of Preproinsulin cDNA from human Whole Genome in mammalian cells and Cloning in Saccharomyces cerevisiae)

B.Sc. in Microbiology Department of Biology, University of Tehran, Iran 1992 – 1996

SELECTED PUBLICATIONS (Peer-Reviewed, out of 20)

GABA promotes β cell proliferation, but does not overcome impaired glucose homeostasis associated with diet induced obesity, (2019) The FASEB Journal 33 (3), 3968-3984.

Molecular Prevalence of Bovine Noroviruses and Neboviruses in Newborn Calves. Arch Virol. 2018; 163(5):1271-1277.

For complete list, please see here: https://scholar.google.com/citations?hl=en&user=rIAJ4isAAAAJ&view_op=list_works&sortby=pubdate

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