Biotechnology Scientist

A curious and detailed minded Scientist with over ten years of experience in Pharma/Biotech R&D and Analytical/QC departments. Recognized for expertise in Molecular and Cell biology, Immunology, Virology, and Protein biology. Strong presentation skills developed through presentations at numerous conferences. Excellent critical thinking skills developed through the review and publication of numerous scientific articles and pharmaceutical documents. A resourceful problem-solver and motivational leader who coaches and develops high performing teams to exceed expectations.

Biological Assay Method Development Validation, Optimizations and Improvements Method Review and Assessment Biotech Lab Operations and Management Project Management Quality Management System Electronic Documentation Systems Veeva, GEODE, Trackwise Laboratory Information Management System (LIMS)

TECHNICAL SKILLS

Cell biology: Cell culture and cell-based assays, screening assays, cell enzymatic assays, cell-counting, cell isolation, cell transfection and transduction, Sterility, Mycoplasma.

Immunology: ELISA and Potency methods, immunoassays, dot blot, flow cytometry, IHC and ICC.

Molecular Biology: Gene cloning, plasmid extraction, qPCR, ddPCR, RT-PCR, DNA/RNA/protein assays, DNA sequencing, restriction digest analysis, gel electrophoresis.

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

Biochemistry: Recombinant protein expression, and purification using dialysis and chromatographic techniques, bacteria fermentation, harvest, feed strategies, and lysis, western blot; SDS-PAGE.

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.

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

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

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

Scheduled and led 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

Lab Manager, QC Analytical Immunochemistry Department (May 2022 – March 2023)

Led a Cell Biology Lab in the Immunochemistry department. Managed 4 lab analysts (direct reports) for QC routine testing and protocols execution.

Directed, scheduled and approved Immunochemistry and Cell based assays (including CHO cells).

Collaborated with other departments for protocol execution in the Immunochemistry department.

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

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

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

Actively contributed to cross functional meetings and presented projects for the department.

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

Managed analysts training and performance using iShift and ADP.

Scientist, QC Analytical Excellence Department (May 2021 – May 2022)

Oversaw/ led Immunochemistry, Cell Biology and Animal Tests improvement and troubleshooting.

Led and performed method optimizations, improvements, and re-validation using FDA/USP/EP/ICH/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, investigation in Electronic Quality Managements system, Phenix.

Reviewed scientific reports and protocols for application into vaccine development and made recommendations.

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 Fellow, Physiology Department

Executed molecular biology, protein expression, and immunology tests including qPCR, ddPCR, ELISA, and immunochemistry, 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.

Razi Vaccine and Serum Research Institute (RVSRI), Karaj, Iran January 2009 –September 2014

Research Scientist and Lab Manager, R&D Department

Led and trained ten staff with effective communication, resulting in efficient teamwork and opening a new line on rotavirus vaccine development in the organization.

Drove Bovine Rotavirus Vaccine development project, resulting in finding two most prevalent rotavirus strains in the area of study.

Purified and scaled up two most prevalent Rotaviruses (G6 and G10) in the MA104 cell line.

Spearheaded master and working cell bank and virus bank culture to be ensured the quality.

Received an award for an international liaison with CHU Enteric Virus Reference Lab (Dijon, France).

Improved scaling up of the culture of Haemophilus influenza to the pilot fermenters to be used for Hib vaccine development.

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

Research Scientist, Virology Department

Led an international liaison for studying the prevalence of Enteric Viruses in Calves. This was concurrent with RSVRI Research Scientist and Lab Manager role.

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.

Institute of Biochemistry and Biophysics (IBB), University of Tehran, Iran 2008

Postdoctoral Fellow, Biophysics Department

Executed molecular biology and cell culture techniques for evaluating a novel porous scaffold from poly(lactic-co-glycolic acid)/hydroxyapatite, resulting in introducing a new scaffold for tissue engineering application.

Authored, reviewed and published papers with detailed results on evaluating of the new scaffold.

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

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

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

SELECTED PUBLICATIONS (Peer-Reviewed, out of 20)

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

An abbreviated protocol for in vitro generation of functional human embryonic stem cell-derived beta-like cells, (2016) PLoS One 11 (10), e0164457.

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.

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