Chee Xiong Email and Phone Number
CGT | Process Improvement | Risk Management | Ensuring safe delivery of life saving products at
@
Kyverna Therapeutics
Chee Xiong's Location
Stockton, California, United States, United States
Chee Xiong's Contact Details
Chee Xiong work email
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Chee Xiong personal email
n/a
Chee Xiong phone numbers
About Chee Xiong
Focuses: Allogenic + Autologous Cell Therapy / CAR-T Manufacturing, Process Development & Process validation, Risk Management, Team Work, Volleyball.
Chee Xiong's Current Company Details
Kyverna Therapeutics
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CGT | Process Improvement | Risk Management | Ensuring safe delivery of life saving products
Chee Xiong Work Experience Details
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Senior Process EngineerKyverna Therapeutics Oct 2023 - PresentEmeryville, California, Us• Define the process for and execute the cGMP manufacturing process transfer to an external contract development and manufacturing organization (CDMO). • Ensure the manufacturing process meets all regulatory and scientific requirements as appropriate for clinical manufacturing according to regional regulatory requirements.• Implement, monitor and manage the technical capability of the manufacturing process, including establishing, monitoring, and refining critical process parameters to consistently meet key quality attributes through all stages of development. • Serve as technical interface between external and internal groups to lead troubleshooting and process improvement efforts. • Implement the Process Monitoring Program to establish and track process performance across the network.• Provide subject matter expert input into process design, comparability, and change control studies and systems.• Contributes information related to the process for regulatory applications and amendments.
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Cmc ConsultantOrca Bio Aug 2023 - Oct 2023Menlo Park, Ca, UsShort-term contract role.Cell Therapy Late Phase Development / CMC / Process Characterization -
Process Engineer - Technical OperationsSequoia Consulting Group,Llc Nov 2021 - May 2023San Diego, California, UsProcess Engineering Consultant to a Clinical Stage Cell Therapy Client, providing strategic and technical inputs on the iNKT Product Development - Provide a systematic and phase-appropriate approach to demonstrate the iNKT cell process capability and scale-up through feasibility and engineering runs as part of Technology Transfer- Evaluate, identified, and refined TPP/QTPP, CQAs, CPPs, KPPs, and CMAs - Define process operating ranges, acceptable ranges, and design space requirements for process understanding and performance optimization, and perform gap analysis/risk assessment. - Perform process monitoring and SME support (manufacturing data summary and analysis, data presentation),- Support Root Cause investigations and Deviations using a systematic approach with problem-solving tools such as Fishbone, 5 whys, etc- Work cross-functionally and collaboratively with the internal CMC team and CDMOs to meet company milestones timely and drive MSAT deliverables in cell therapy- Manufacturing. Establishing the process for aseptic fill operation for iNKT. Support process execution with prodigy instrument, Miltenyi generated records and GMP readiness. -
Process Engineer Iii - Manufacturing Science & TechnologyKite Pharma Mar 2021 - Nov 2021Santa Monica, California, Us• Perform process support as process development representative for manufacturing siteo Author process and product impact assessmentso Lead cross functional teams to perform root-cause investigations and deviation resolutiono Monitor process performance through data-based trendingo Data based deviation resolution and improvement projectso Support manufacturing through risk assessments and remediation measureso Collaborating with technical and operational stakeholders, write and review SOPs, batch records, and other operational related documents as needed• Lead continuous improvement initiatives• Design studies, author protocols and reports, for process characterization and validation studies• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing• Represent process development for global change management and process related CAPAs• Support regulatory inspections and projects for regulatory commitments• Act as sending unit or receiving unit lead for technology transfers and new product introductions• Advanced understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes• Conducts technical and scientific training• Act as communication channel between global organizations and site manufacturing -
Process Engineer Ii - Manufacturing Science & TechnologyKite Pharma Mar 2020 - Mar 2021Santa Monica, California, Us
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Process Engineer I - Manufacturing Science & TechnologyKite Pharma Aug 2019 - Mar 2020Santa Monica, California, Us
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Manufacturing Technology SpecialistKite Pharma Aug 2018 - Aug 2019Santa Monica, California, Us
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Graduate Student Consultant - Project CoordinatorBiomarin Pharmaceutical Inc. Aug 2017 - May 2018San Rafael, Ca, UsServe as Project Coordinator and is responsible for running team meetings, building consensus within the team, and guiding the direction of individual assignments.The purpose of our project is to conduct a feasibility study on a cGMP manufacturing downstream process of a protein-based drug product with a focus on continual process immunoaffinity purification. This study will be delivered as a business case evaluation with a final recommendation on a purification methodology based on business strategy, regulatory, COGS, SME, scientific and engineering considerations. This team master's project is the capstone of Keck Graduate Institute's Master of Business and Science program, sponsored by BioMarin Pharmaceuticals Inc. -
Process Technology & Engineer InternBiomarin Pharmaceutical Inc. May 2017 - Aug 2017San Rafael, Ca, UsI work within the Process Technology and Engineering (PT&E) Group on several projects to help develop and expand our business processes in order to help drive decisions relating to facility needs, in addition to helping align future equipment and facility requirements. PT&E works in collaboration with manufacturing and other engineering groups to solve interdisciplinary problems, develop new technology for bioprocessing, and model/forecast future facility and equipment needs. As such, the projects require collaboration with other groups in Technical Operations such as Manufacturing Sciences and Engineering Services.This internship experience provided valuable perspective into bioprocessing operations in a GMP environment. I had the chance to interface with several groups involved with bioprocessing operations and gained insight into the complexities of upstream and downstream activities in bioprocessing, as well as developed skills such as data mining, research analysis and presentation experience.
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Graduate Student Consultant - Budget And Documentation OfficerBiomarin Pharmaceutical Inc. Jan 2017 - May 2017San Rafael, Ca, UsServe duel roles as the TMP Budget Officer and Documentation Officer: - As a Budget officer, I frequently meet with KGI's TMP Administrator, faculty advisor, and team members to assure that an accurate real-time record of expenses is maintained. - As a Documentation Officer, I assure that team documentation is up-to-date and is responsible for the liaison's (or the legal staff of BioMarin) approval on all confidential and non-confidential presentations.The purpose of this project is to develop a tool to evaluate parameters of the manufacturing process based on their impact on commercialization. This tool is a stage-gated, real options-based decision tree, highlighting what would be required to implement each type of change at a given stage of development, considering cost, timeline, and regulatory requirements. The development of this analytical tool required research in areas such as rare disease clinical development, regulatory affairs, bioprocessing and manufacturing, and relevant aspects unique to the company including process development approaches and priorities.This team master's project is the capstone of Keck Graduate Institute's Master of Business and Science program, sponsored by BioMarin Pharmaceuticals Inc.
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InstructorLife First Training Center Mar 2015 - Jun 2016I taught the American Heart Association BLS for Healthcare Provider Course. In addition, I am trained to teach Heartsaver courses including Heartsaver First Aid, Heartsaver CPR, Heartsaver AED, Heartsaver Pediatric First Aid, Heartsaver CPR in Schools, Heartsaver Bloodborne Pathogen, and Family and Friends CPR with the proper instructor manual
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Sales RepresentativeNyia-Yi Farms Jan 2011 - Jun 2016Lead customer service team and handle daily revenue for Nyia-Yi Farms in several farmer's markets.
Chee Xiong Skills
Digital Marketing
Strategic Communications
Entrepreneurship
Social Media
Community Outreach
Fundraising
Social Networking
Intercultural Communication
Mindfulness Based Stress Reduction
Research
Commercial Real Estate
Property Management
Event Planning
Networking
Nonprofits
Public Speaking
Microsoft Office
Chee Xiong Education Details
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Keck Graduate InstituteClinical And Regulatory Affairs -
California State Polytechnic University-PomonaGeneral
Frequently Asked Questions about Chee Xiong
What company does Chee Xiong work for?
Chee Xiong works for Kyverna Therapeutics
What is Chee Xiong's role at the current company?
Chee Xiong's current role is CGT | Process Improvement | Risk Management | Ensuring safe delivery of life saving products.
What is Chee Xiong's email address?
Chee Xiong's email address is ch****@****nds.com
What is Chee Xiong's direct phone number?
Chee Xiong's direct phone number is +195274*****
What schools did Chee Xiong attend?
Chee Xiong attended Keck Graduate Institute, California State Polytechnic University-Pomona.
What skills is Chee Xiong known for?
Chee Xiong has skills like Digital Marketing, Strategic Communications, Entrepreneurship, Social Media, Community Outreach, Fundraising, Social Networking, Intercultural Communication, Mindfulness Based Stress Reduction, Research, Commercial Real Estate, Property Management.
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