Balazs Csoka brings more than 15 years of experience to BioCentriq, where he combines his knowledge of cGMP and quality disciplines, his extensive experience in bio analytical assays, and his in-depth scientific knowledge in the characterization of immune cells using various bioanalytical techniques to manage projects while ensuring quality. Previously the QA for QC Lab Oversight at Legend Biotech, he’s also served as the senior supervisor at Bristol Meyers Squibb CTDO, an Associate Research Scientist at Columbia University, and a Postdoctoral Scientist at Rutgers University’s Center for Immunity. Balazs has successfully lead quality projects in facilitating the commercialization of 3 CAR-T cell therapies (ide-cel, lisocel, and cilta-cel), provided QA oversight of method validation and method transfer for cilta-cel, established a Centralized Critical Reagent Qualification Lab in supporting clinical and commercial QC testing of ide-cel and liso-cel, and provided QA oversight of qualification and validation of a Lentiviral Vector (LVV) manufacturing facility for supporting commercial manufacturing of cilta-cel. He has a Master of Science in Molecular Biology (Biochemistry) and a Ph.D. in Molecular Medicine from the University of Debrecen.

Dr. De Silva completed his Ph.D. in Chemical Engineering from Columbia University, specializing in polymer-based drug delivery systems. He later co-founded a startup company to commercialize work in this area. Dr. De Silva has over 8 years of experience in research & development and has published several peer-reviewed journal articles on his work in specialty polymers. Prior to joining BioCentriq, Dr. De Silva worked in chemical distribution at BrenntagNorth America and Consulted for Academic Venture Exchange. In his current role, Dr. De Silva leads the Business Development function for BioCentriq.

Elzbieta has worked in manufacturing roles for more than 20 years. She has held roles in product development, device manufacturing, and more for companies such as Becton Dickinson, Vyteris, Guardian, and Ivers Lee. Her experience includes working in electrochemistry laboratories, where she was responsible for lab clean up, maintenance, and calibration; mastering a variety of lab equipment; performing electrochemistry tests and experimentation; and manufacturing FDA-approved products. At BioCentriq, she applies her decades of experience to the operations team, ensuring smooth and proper processes for each project.

Erikson Calcano brings specialized experience to the BioCentriq team after serving as a Manufacturing Associate for CAR-T at Bristol Meyers Squibb, where he manufactured human blood derived cell therapies per SOPs in a controlled cGMP cleanroom environment through cell culture and performed aseptic manipulations in an ISO5/Grade A and ISO7/Grade B environment to minimize contamination. He’s adept at performing personnel and environmental monitoring, sterility testing, and sample aliquoting for PBMC Isolation and Drug Product Harvest. Fully qualified in culture initiation and transduction process, Erikson is also qualified in the Sample Management and Environmental Management roles of CELabs to assist in the movement and collection of sterility samples and creation of CELabs plans. With teaching experience in university labs, Erikson earned his bachelor’s and master’s degrees in Biology from Seton Hall University.

Gabriella has a Bachelor of Science in Chemical Engineering from Villanova University, where she worked on the optimization of gene and cell therapies and conducted biotechnology research in the lab of Dr. Jacob Elmer. This hands-on experience in a biotechnology research lab is where she gleaned techniques for the transfection and analysis of plasmid DNA into various cell lines. Her focus was on performing research to optimize gene and cell therapies using non-viral vectors. She has also worked in the lab of Ames Corporation and is a member of the Society of Women Engineers as well as the National Society of Professional Engineers. As an Associate Engineer for Gene Therapy at BioCentriq, she has experience using a variety of equipment for upstream and downstream processing, scale-up, and optimization for cell and gene therapy products. She’s skilled in data analysis, client interface, and technical writing, and  along with her primary role in process development, she has demonstrated experience in cGMP manufacturing environments and documentation.

Halima Mezhoud brings multiple years of experience as a microbiologist in academia and the pharmaceutical regulated environment to the BioCentriq team. She previously served as a QC Microbiologist II for Teva Pharmaceuticals, where she collaborated with site departments to ensure all microbiological sampling (water, EM, swabbing, raw materials, etc.) was performed according to schedules. She also shipped samples to external microbiology testing labs; ensured EM media was qualified and approved for use: pH, Sterility, growth promotion; performed Environmental Monitoring and water testing: bioburdens, coliforms, Pseudomonas aeroginosa and Burkholderia cepacia; and monitored the receipt of test results from external testing facilities for all sample types. Prior to that, she was a QC Microbiologist II at AbbVie, a Lab Researcher at Infinity BiologiX (IBX), and a lecturer at Rutgers University for the department of Biochemistry and Microbiology. Halima holds her bachelor’s, master’s, and Ph.D. in Biology from the University of Bejaia.

Dr. Ioannidis completed her B.S. in Chemistry at Beijing Normal University and her Ph.D. in Chemistry at NJIT, with a focus on protein engineering by directed evolution. Before working at BioCentriq, she served as the associate director of microbiology at TAXIS Pharmaceuticals, where she commissioned a new R&D facility and transferred its biology division from an academic setting into a successful industrial operation. She more recently worked as associate director of sales and marketing for ACS Scientific.

James Schluter brings 20+ years of experience in the manufacturing and R&D sectors of the pharmaceutical industry to his role as Head of IT at BioCentriq. James has an outstanding track record of implementing validated and cost-effective systems in a regulated environment, and has overseen resource management, project management, application development, infrastructure, client services/desktop support issues, and process automation. Formerly the Senior Director of IT Infrastructure & Operations at Accord Therapeutics, Inc., James provided strategic direction to and operational oversight over Acorda’s infrastructure, networking, operations, and manufacturing teams while building, developing, and leading teams to promote optimal communication and teamwork, thereby improving the support process. Prior to that, he was the Associate Director of MFG and R&D Systems at Purdue Frederick Co. Inc./Purdue Pharma L.P., where he served as an IT liaison between manufacturing and R&D executive management to ensure business and IT initiatives were aligned. In each of his roles, James has been charged with handling the financial responsibilities for multiple location’s operational and IT capital project budgets. James earned his BS in Information Technology from Ramapo College and his MSIS from Stevens Institute of Technology. He was a Recipient of the Q3 2012 Purdue IT Outstanding Achievement Award and a Recipient of the Annual 2012 Purdue IT Outstanding Achievement Award. He holds multiple professional affiliations, including with ISPE (Industrial Society of Pharmaceutical Engineers), PMI (Project Management Institute), New Jersey Planning Officials, Stevens Institute Alumni, and the Delta Mu Delta National Honor Society.

With ten years of experience, Jason Chou is an experienced bioengineer with demonstrated success in solving problems through software and process development and data analytics. Prior to joining BioCentriq, Jason held similar roles at Genetech, Bayer, and more. He earned his Bachelor of Science in Bioengineering from the University of California San Diego.

Jean Han comes to BioCentriq as a Senior Research Associate after working as a QC Analytical Associate at Minaris Regenerative Medicine, where she lead and collaborated on client projects; worked closely with clients on tech transfers; assisted in QC method developments, such as protocols and reports; and executed test methods and procedures and equipment and method qualification/validation. She also ensured compliance with applicable SOPs and GDP (Good documentation practices) as well as cGMP/GCTP requirements and investigated OOS (Out of specification), OOT (Out of trend) and/or non-conforming test results. Jean earned her Bachelor of Science in Chemical Engineering from Rowan University.

Jeremy Pecoraro brings more than 20 years of technical experience to his role at BioCentriq as Equipment Engineer. Formerly a Senior Calibration/Metrology Specialist at Integra LifeSciences, he oversaw and supported all approved vendor activities for calibration and certification for all cGMP and non cGMP areas, including manufacturing, QC, and R&D. As a subject matter expert, he supported the review of all calibration and certification documents to identify and initiate Out of Tolerance (OOT) and Non-Compliance (NC) investigations as needed. He also supported all SOPs relating to calibration and certification for all equipment and instruments. Prior to that, his roles included Field Calibration Technician at ENV Services, Calibration Technician at Roche Molecular Systems, and Revenue and Billing Analyst at Labcorp. His vast technical knowledge includes IQ/OQ, validation, autoclaves, RPM speed, pH/conductivity, sealers, AC & DC electronic, PLC systems, Freezers, centrifuges, and more. Jeremy earned his Electronics Engineering Degree from DeVry College of Technology.

Judit Hortobágyi, PMP, brings years of experience in project management, procurement, and service management to her role as Project Manager at BioCentriq. She previously served as the Project Manager/Site PMO Manager for Novartis, where she led and managed T-Charge, a next generation CAR-T platform. She also led the set up of Novartis’ Morris Plains facility for the clinical launch of YTB323 and PHE885. She oversaw supply chain logistics to ensure the successful and timely delivery of needed materials; designed and standardized project-related governance processes; led the overall execution of multiple technical projects regarding initiation, budgeting, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements; and more. She holds multiple certifications, including the Project Management Institute’s PMP certification and the BioPharma Institute’s GMP Professional Certification & GMP for Microbiology and Contamination Control Professional Certification. Judit earned her Associate of Applied Science in Business Management from Union County College and her Bachelor of Arts in Psychology from Thomas Edison State University, and she is a member of the Project Management Institute.