Li Ren, Ph.D. Email & Phone Number
@chimerictherapeutics.com
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Who is Li Ren, Ph.D.? Overview
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Li Ren, Ph.D. is listed as Chief Technology Officer at Cure Genetics at 克睿基因 Cure Genetics, based in United States, United States, United States. AeroLeads shows a work email signal at chimerictherapeutics.com and a matched LinkedIn profile for Li Ren, Ph.D..
Li Ren, Ph.D. previously worked as Chief Technology Officer at 克睿基因 Cure Genetics and VP, Head of Technical Operations at Chimeric Therapeutics Asx: Chm. Li Ren, Ph.D. holds Doctor Of Philosophy (Ph.D.), Biochemistry And Molecular Biology from Peking University, Ocean University Of China (Co-Trained).
Email format at 克睿基因 Cure Genetics
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About Li Ren, Ph.D.
Accomplished biotech professional and executive leader with 20+ years of experience in developing and advancing cell therapy drug candidates from pre-clinical to commercial licensure. Strong expertise and leadership in process development and manufacturing, analytical development and validation, viral vector, technology transfer, quality compliance, and CDMO management. Effective and experienced team leader who has built strong functional teams and led successful cross-functional matrix teams for cell therapy development with effective interface with research, non-clinical, clinical development and other organizations, both internally and externally.• Extensive experience in leading Cell & Gene Therapy CMC teams, spanning process and analytical development, manufacturing, technology transfer, MS&T, and CMC leadership for both early-stage and late-stage development.• Led the development of multiple allogeneic & autologous cell therapy products, including CAR T cells, TCR cells, NK cells, and mesenchymal-like stem cells.• Significant regulatory filing experience for US, EU, and Japan markets, including IND, CTA, BLA, MAA, J-CTN, 510(k), 361 HCT/P.• Extensive quality compliance experience (product release, deviation/CAPA/change control management, quality agreements, audits, etc.).• Excellent organization, people, communication, presentation, and project management skills.
Listed skills include Cell, Biotechnology, Microbiology, Cell Culture, and 31 others.
Li Ren, Ph.D.'s current company
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Li Ren, Ph.D. work experience
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Vp, Head Of Technical Operations
Oversees the Process Development, Analytical Development, and Manufacturing of Chimeric Therapeutics development pipeline.
Director, Global Manufacturing Science & Technology, Cell Therapy Development & Operations
- Oversaw technology transfer (process & analytical) of Juno cell therapy pipeline products to a GMP facility and provided technical support to both GMP manufacturing & QC testing to enable clinical trials.
- Established the site MS&T function and built the MS&T team to lead tech transfers.
- Supported multiple IND submissions for pipeline products to enable clinical studies.
- Managed functional objectives, budget, resource planning, and hiring.
Associate Director, Car T Cmc & Technology Development, Biologics
- Established CAR T cell supply chain in EU/Japan to enable clinical trials towards commercial licensure
- Led multiple CAR T technology transfer (process & analytical) from Juno Therapeutics to EU CMO and successfully established the clinical supply chain in EU to enable clinical trials by working with external & internal.
- Supported regulatory filing for CTA, MAA, J-CTN of JCAR017 in EU and Japan.
- Provided technical support to Celgene global Quality team, including quality agreements, inspections, site audits, QP audit, mock PAI, etc. for quality oversight at CMO & CRO.
- Managed contracts, budgets, and timelines with the EU CMO.
Associate Director, Cell Process Development, Technical Operations
- Early-stage project team lead to IND for TCR and NK cell therapies.
- Led CMC efforts to advance a TCR cell product towards IND and clinical phase I.
- Developed the process of a natural killer cell product to support clinical phase I study.
- Led efforts across Tech Ops to characterize the process, implement process changes, and troubleshoot manufacturing problems related to allogeneic placenta-derived adherent cells to support clinical phase I & II studies.
- Represented CMC on project teams for multiple cell therapy products, and led CMC initiatives in development, supply, and quality concerns.
Principal Bioengineer, Senior Bioengineer
- Early-stage project team lead to IND for allogeneic placenta-derived cell therapies
- Oversaw process development of allogeneic placenta-derived cell therapies, including the design of product attributes, scale-up, process characterization & validation (QbD, risk assessment, DOE), manufacturing support.
- Led efforts on the development of an allogeneic cell therapy to enable clinical trials, including cell bank generation, medium optimization, process development & characterization, scale-up of upstream process with.
- Led efforts across process development, analytical R&D, clinical production, and quality operation for developing & implementing phase II, EU-compliant process in clinical manufacturing.
Research Scientist
Formulated and implemented approaches to develop fermentation process conditions that maximize enzymatic activity and biomass levels of proprietary biocatalysts.
Li Ren, Ph.D. education
Doctor Of Philosophy (Ph.D.), Biochemistry And Molecular Biology
Mini-Mba, Biopharma Innovation Program
Frequently asked questions about Li Ren, Ph.D.
Quick answers generated from the profile data available on this page.
What company does Li Ren, Ph.D. work for?
Li Ren, Ph.D. works for 克睿基因 Cure Genetics.
What is Li Ren, Ph.D.'s role at 克睿基因 Cure Genetics?
Li Ren, Ph.D. is listed as Chief Technology Officer at Cure Genetics at 克睿基因 Cure Genetics.
What is Li Ren, Ph.D.'s email address?
AeroLeads has found 1 work email signal at @chimerictherapeutics.com for Li Ren, Ph.D. at 克睿基因 Cure Genetics.
Where is Li Ren, Ph.D. based?
Li Ren, Ph.D. is based in United States, United States, United States while working with 克睿基因 Cure Genetics.
What companies has Li Ren, Ph.D. worked for?
Li Ren, Ph.D. has worked for 克睿基因 Cure Genetics, Chimeric Therapeutics Asx: Chm, Bristol-Myers Squibb, Celgene, and Celgene Cellular Therapeutics.
How can I contact Li Ren, Ph.D.?
You can use AeroLeads to view verified contact signals for Li Ren, Ph.D. at 克睿基因 Cure Genetics, including work email, phone, and LinkedIn data when available.
What schools did Li Ren, Ph.D. attend?
Li Ren, Ph.D. holds Doctor Of Philosophy (Ph.D.), Biochemistry And Molecular Biology from Peking University, Ocean University Of China (Co-Trained).
What skills is Li Ren, Ph.D. known for?
Li Ren, Ph.D. is listed with skills including Cell, Biotechnology, Microbiology, Cell Culture, Assay Development, Immunology, Cell Biology, and Process Development.
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