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Ching Lee is a MSAT Sr Director at Kite Pharma at Kite Pharma. They possess expertise in biotechnology, gmp, validation, pharmaceutical industry, technology transfer and 16 more skills.
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Sr DirectorKite Pharma Oct 2022 - PresentSanta Monica, California, UsMSAT Viral vector -
Msat DirectorKite Pharma Dec 2019 - Oct 2022Santa Monica, California, UsMSAT Director for viral vector manufacturing and External Manufacturing
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Principal Process EngineerKite Pharma Aug 2018 - Feb 2020Santa Monica, California, UsTech Transfer and Technology Implementation to clinical and commercial manufacturing.Establish business processes for technology implementation that includes RACI development, process flow diagrams, and cross functional alignment.Business and workflow improvements using OE principles.
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Sr Project ManagerGenentech Dec 2008 - Aug 2018Lead/Manage CMO Contract for Commercial Rheumatoid Arthritis Product working with cross functional team. Escalate and update Sr management on milestones, deliverables, and yearly forecast. Tech Transfer Leader for commercial and clinical products. Develop tech transfer timeline using MS projects by aligning with team on milestones and deliverables Tech Transfer Business Process Manager with focus on driving for efficiencies and timeline reductionManage/Lead technical Projects to improve or streamline productionManage department budget to meet yearly goalsManage department project portfolio and strategy in alignment to meet company goalsLead facility fit assessments for new productsFaculty fit evaluation for potential new products to manufacturing faculty
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Scientist/ManagerBiogen Idec Jul 2002 - Nov 2008Manage Cell Culture Tech Transfer group that transferred clinical and commercial products to manufacturingCMC Leader for Phase 1 program, leading cross functional team to develop and manufacture clinical material under accelerated timelinesPerformed supplier technical audits for raw materials used in process development and manufacturingStreamlined our tech transfer business processesProvided floor support during tech transfer as Technical SMEExecuted small scale studies to support tech transfersAssessed deviations and investigations, as cell culture SME during manufacturing campaigns
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Manufacturing SupervisorAmgen Jan 1998 - Jun 2002Upstream Manufacturing: E.Coli and Cell Culture ManufacturingFermentation area lead in clinical and commercial manufacturing responsible for scheduling and executing production activitiesTrained staff on critical manufacturing operations and equipment consisting of bioreactor operations, aseptic technique, microfiltration, centrifugation, and homogenizersResponsible for coordinating QC sample plan and execution during manufacturing campaignsAuthored Annual Product Reviews for commercial productExecuted process and cleaning validation for commercial productExecuted SIP cleaning validationBatch Record review and reconciliation
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Qc MicrobiologyAmgen Aug 1993 - Jan 1998QC Testing for microbial contamination on samples from manufacturing, EM, and investigationsLead Sterility testing area that included scheduling daily work, perform testing on drug substance and drug product samples. Reviewed and approved resultsResponsible for generating monthly reports for management reviewAudit Sterility area for compliancePerformed Media Verification testingBioburden Testing
Ching Lee Skills
Ching Lee Education Details
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California State University, NorthridgeMaster Of Business Administration (Mba) -
California State University, Long BeachMedical
Frequently Asked Questions about Ching Lee
What company does Ching Lee work for?
Ching Lee works for Kite Pharma
What is Ching Lee's role at the current company?
Ching Lee's current role is MSAT Sr Director at Kite Pharma.
What is Ching Lee's email address?
Ching Lee's email address is cl****@****rma.com
What schools did Ching Lee attend?
Ching Lee attended California State University, Northridge, California State University, Long Beach.
What skills is Ching Lee known for?
Ching Lee has skills like Biotechnology, Gmp, Validation, Pharmaceutical Industry, Technology Transfer, Sop, Fda, Capa, Lifesciences, Change Control, Process Simulation, 21 Cfr Part 11.
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