Quality Assurance Personnel

Karen Sealana

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.

Kunjan Kamdar

QA Specialist

Kunjan holds a Master of Science in Regulatory Science. She joined Stanford Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2017. In her past roles in Quality Assurance, she has managed quality systems such as Deviations, CAPA, Internal Audit, and Supplier Qualification. She has also been responsible for Manufacturing Batch Record Review, Stability Program Review and Training. She has over 8 years of combined experience working in Pharmaceutical Marketing and Quality Assurance. 

Miguel Valente

Senior QA Specialist

Miguel joined the Laboratory for Cell and Gene Medicine as a Quality Assurance Associate in 2018. He received his Bachelor of Science degree in Biological Sciences from the University of California - Davis, and has a M.B.A. from California State University - East Bay. He has 20 years of combined experience working in Quality Control and Quality Assurance.

In his past roles, he has supervised the Quality Control Environmental Monitoring, Raw Material Testing, and Sample Management groups, and provided Quality Assurance oversight of both Quality Control and Media Prep/Reagent groups. He has also been responsible for Deviation/CAPA management, Change Control, Equipment Validation, Internal/External Audits, and Training.

 

Jenny Chao

QA Specialist

Jenny joined the LCGM in September 2019. She holds a Bachelor Degree in Chemical Engineering from UCLA. She has over 16 years of cGMP experience working in Biotech and Pharmaceuticals Companies.  In her past roles, she has worked in Manufacturing Operations, Quality Control, Quality Assurance Operations and Quality Assurance Validation.

Arlene Ajoste

QA Manager

Arlene has over 13 years work experience in a GMP environment in both Manufacturing and QA roles. In her past roles, she also lead and developed staff for various manufacturing processes and process improvement projects. Arlene joined LCGM in March 2017 to gain cGMP experience in Cell and Gene Therapy by supporting Clinical Manufacturing Operations. She soon found development opportunities in Quality Systems and has been actively supporting the development and implementation of Quality Systems.

 

Arlene holds a B.S in Business Management from Menlo College.

Aemal Aman

QA Specialist

Aemal Aman joined the Quality Assurance Team at LCGM in November 2017.  He holds a Bachelors Degree in Biological Sciences with a Minor in Business from San Jose State University.  He has over 15 years of cGMP experience in the Biopharmaceutical Industry in roles ranging from Commercial Manufacturing (Protein Purification), Quality Control (Raw Material Release Testing, In-process and Final Product Release Testing), Plant Manufacturing QA Support (Review of Batch records, Discrepancy Report, QC Assay Testing Review and Sign off for Certificate of Analysis for Product Release).  In his role at LCGM he supports the building of Quality Systems at the facility including  providing support for manufacturing, upkeep and compliance of the facility, and materials management of raw materials for GMP use.

Jasminka Jakovljevic

Administrative Associate I

Jasminka Jakovljević joined the Laboratory for Cell and Gene Medicine as Materials Management Specialist in May 2016. She is responsible for the materials management and administrative operations of the department.

Prior to joining Stanford, Jasminka was Account Manager at the Société Générale Group in New York, where she was in charge of overseeing and managing the financial and administrative affairs of International Banks and Institutions investing on the U.S. market.

Jasminka studied languages at the Belgrade University in Serbia, and is fluent in English, French and Serbian. 

Priyanka Patel

Senior QA Specialist

Priyanka joined the Laboratory for Cell and Gene Medicine (LCGM) as a Quality Assurance Associate in 2018. She received her Master’s in Science from University of Rhode Island.

Prior to joining LCGM, Priyanka gained 3 years of cGMP experience working for pharmaceutical companies. She has previously managed change control, batch record review, equipment validation and training. At LCGM she provides quality systems support for Phase III clinical trial of cellular therapy for Epidermolysis Bullosa led by Dr. Jean Tang at Stanford University.