Quality Control Personnel
Director of Quality
Karen leads the Quality Assurance and Quality Control departments and overall GMP compliance for the Laboratory for Cell & Gene Medicine. Karen has a Bachelor of Science degree in Biological Sciences from California State University, Sacramento and is Six Sigma Green Belt certified. She has over 12 years of biopharmaceutical leadership experience in Quality including work in Quality Control, Quality Systems, and Quality Assurance. She has provided Quality Assurance oversight of Commercial and Phase I/II/III Clinical Manufacturing of bulk drug substance to final drug product, Supply Chain/Inventory Management, QC Environmental Monitoring, and Equipment Cleaning Verification. Throughout her Quality career, her emphasis has been Quality System infrastructure improvements, driving process efficiencies, and strengthening overall compliance to regulations.
Nara Vu received her Bachelor of Science degree in Biotechnology from University of California, Davis. Nara has 3 years of experience in cGMP Manufacturing and Quality Control. Prior to her transition to Stanford, Nara worked as a QC analyst at Boehringer Ingelheim, where she gained experience in tech transfer, assay validation as well as release and stability testing in cGMP setting for clinical and commercial biologics.
In her role at Stanford LCGM, Nara supports QC assay development and testing for a Phase III clinical trial product.
Peter received his Bachelor of Art degree in Biological Sciences with an emphasis in Immunology from San Jose State University in 2016. While at SJSU, Peter was a member of Dr. Tzvia Abramson's Immunology Lab experimenting with Mesenchymal Stem Cells as a potential vehicle for antigen presentation against Bordetella pertussis, the causative agent of Whooping Cough. Prior to his transition to the Stanford LCGM, Peter worked as an Immuno-Oncology R&D Research Assistant at BD Biosciences, in San Jose, CA, where he became proficient in flow cytometry, along with cell culturing of various cancer stem cell lines. He then acquired cGMP experience while working as a Manufacturing Associate at Asterias Biotherapeutics, Inc., in Fremont, CA, where he participated in the cell banking of Human Embryoic Stem Cells for their ongoing Phase I/IIA clinical trials. Recently, Peter joined the Stanford LCGM as a Manufacturing Specialist but has since transitioned in his current role as a Quality Control Associate. He hopes to continue supporting LCGM projects in his new role.
“Plasmacytoid dendritic cell-derived IFN-α modulates Th17 differentiation during early Bordetella pertussis infection in mice”. Wu, V., Smith, AA., You, H., Nguyen, TA., Ferguson, R., Taylor, M., Park, JE., Llontop, P., Youngman, KR., Abramson, T. Mucosal Immunology, Nature Publishing Group, published online October 14, 2015. Doi:10.1038/mi.2015.101
Aladdin received his Bachelor of Science degree in Biological Sciences with a minor in Chemistry from California State University, San Jose, CA. Aladdin began his career with Becton and Dickenson & Company (BD Biosciences sector, San Jose, CA) gaining unparalleled 9 years’ experience in the Flow Cytometry space, while also establishing himself as a respected Quality Control Scientist. In addition to Flow Cytometry experience while in BD, Aladdin gained experience in Next Generation Sequencing (NGS) space including preparing libraries, sequencing on Illumina platforms, and data analysis and interpretation. At LCGM, Aladdin is responsible for supporting various QC flow assay development, improvement, validation, and testing different Phase I/II clinical trial products.
Kit Man Yeung
Bio coming soon.
Jonathan Wong received his Bachelor of Science degree in Neurobiology, Physiology, and Behavior from University of California, Davis. Jonathan has 3 years of experience biotech and healthcare. In his most recent position with BioMarin Pharmaceutical, Jonathan worked as a QC analyst and supported the operations of the QC Microbiology group. He performed Quality Control procedure in environmental monitoring and analytical chemistry assays. Additionally, he supported facility qualification, method development and method validation projects.
With the Stanford LCGM, Jonathan supports the routine QC operations, from assay development and testing, to environmental monitoring.
Thomas Cole received his Bachelor of Science degree in Molecular/Medical Biology with a minor in Chemistry from Bridgewater State University. Thomas has 5 years of experience in Quality Control. Prior to his move to Stanford, Thomas worked as a QC analyst for Organogenesis Inc, and Biomarin Pharmaceuticals. His experience in Quality Control includes cell culture, microbiology, environmental monitoring and analytical chemistry assays, as well as facility qualification, method development and method validation. In his role at Stanford LCGM, Thomas supports QC assay development, testing, and environmental monitoring for Phase III clinical trial product.
Fariba Fazeli, MD
Senior QC Analytical Scientist
Fariba received her M.D. degree from Marche Polytechnic University, Italy. She has more than 20 years of academic and industry experience in immunology, oncology, microbiology, and molecular genetics. Prior to joining LCGM, Fariba was the senior development scientist at IncellDx, where she supported validation of cell based assays such as Fluorescent In Situ Hybridization and Multicolor Flow Cytometry for diagnosis of cervical, lung, breast, bladder cancer and various life-threatening infectious diseases. Her projects were from the earliest phases of research through process development and optimization of assays for IVD/CE-IVD prodcuts.
At LCGM, Fariba is responsible for supportting various QC assay qualifications and validations for clinical production of products at different phases according to ICH and FDA guidelines.
Publications and Abstracts
Cell by cell immuno- and cancer marker profiling for non-small cell lung cancer (NSCLC) tissue sample using non-enzymatic tissue dissociation and high-parameter flow cytometry. AACR Annual Meeting 2018; April 14-18, 2018; Chicago, IL. 10.1158/1538-7445.AM2018-2112 Published July 2018
Characterizing PD-L1 expression in tumor-associated cells and CTC using IncellDx and Celsee molecular diagnostic technologies. 10.1158/1538-7445.AM2018-635 Published July 2018
Role of polyphosphate in thermophilic Synechococcus sp. from microbial mats. J Bacteriol. 2013 Aug; 195(15):3309-19. Doi: 10.1128/JB.00207-13. Epub 2013 May 17.
Responses of a thermophilic Synechococcus isolate from the microbial mat of Octopus Spring to light. Applied Environmental Microbiology, 2007 Jul; 73(13):4268-78. Epub 2007 May 4.
Phototaxis and Impaired Motility in Adenylyl Cyclase and Cyclase Receptor Protein Mutants of Synechocystis sp. Strain PCC 6803. Journal of Bacteriology, 2006 Oct; 188(20):7306-10.
Azadeh Timnak, PhD
QC Analytical Scientist
Azadeh received her Ph.D. in Bioengineering from Temple University, Philadelphia in 2017 where she developed a novel immunomodulatory wound healing patch and investigated polarization behavior of macrophages in skin wound healing. Over her postdoctoral training at University of Pennsylvania, department of Orthopedic Surgery she studied distribution profile of immune cells in tissues in which, due to a rare genetic disorder known as Fibrodysplasia Ossificans Progressiva, ectopic bone formation had occurred. Prior to joining LCGM, Azadeh was a scientist at Liquid Biotech USA where she optimized a detection method for circulating tumor cells using a telomerase-specific adenovirus. When at Liquid Biotech she wore multiple hats of design of experiments, assay development and data analysis for downstream immunophenotyping of infected cells.
Selected Publications and abstracts:
Detection of viable tumor cells from cryo-preserved buffy coat using the VTX-1 liquid biopsy platform, American Association for Cancer Research, Advances in Liquid Biopsies, January 2020
- Gradient Porous Fibrous Scaffolds: A Novel Approach to Improving Cell Penetration in Electrospun Scaffolds, J Biomed Mater. 2018. PMID: 30129563
- Macrophage Infiltration into Macro-porous Electrospun Scaffolds Initiates a Reparative Inflammatory Response, Tissue Engineering and Regenerative Medicine Annual Conference, December 2017
Negative Pressure Enhanced Cellular Infiltration into Electrospun Scaffolds, PCT/US17/55273
- Graded Porous Scaffolds as Immunomodulatory Wound Patches, PCT/US18/29519
Bio coming soon.