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• 10 years of experience in analytical development and quality control for small molecule, biologics, and cell and gene therapies.• Extensive experience in analytical control strategy, method development, method validation, extended characterizations, stability, lab investigation, change control, and regulatory dossier writing.• Strong technical expertise in liquid chromatography, mass spectrometry, light scattering, and Raman spectroscopy.
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Senior Scientist, Quality AssuranceSana Biotechnology, Inc. Aug 2024 - Nov 2024Seattle, Washington, UsManage GMP quality management system (QMS) and quality events.- Lead, conduct, and write investigations for deviations, laboratory investigations, and out-of-specification investigations.- Lead Change Control Board and perform impact and risk assessments.- Technical writing and review for controlled documents such as SOPs. -
Senior Scientist, Quality ControlSana Biotechnology, Inc. May 2023 - Aug 2024Seattle, Washington, Us- QC lead for allogeneic CAR-T program, responsible for release and stability testing, method transfer and validation, IND authoring, and CDMO management.- Experienced with CRISPR gene-editing reagents, viral vectors, and CAR-T products.
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Scientist, Analytical Development And Quality ControlSana Biotechnology, Inc. Nov 2021 - Apr 2023Seattle, Washington, Us
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Senior Research Associate, Protein Analytical ChemistryGenentech Jul 2018 - Nov 2021South San Francisco, California, Us- Analytical development for monoclonal antibodies and polymer-antibody conjugates. Established analytical control strategy, developed analytical methods, conducted product characterizations to support CMC development and regulatory filings- Technical development projects: multi-attribute monitoring by LC-MS (MAM), multi-dimensional LC-MS, host cell protein analysis, and Raman spectroscopy -
Research Associate, Protein Analytical ChemistryGenentech May 2016 - Jun 2018South San Francisco, California, Us
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Research Associate, Analytical ChemistryTheravance Biopharma Us, Inc. Jan 2015 - May 2016South San Francisco, Ca, UsDeveloped high-throughput purification and analysis of small molecule libraries using LC-MS, SFC-MS, and automated liquid handlers. -
Intern, Protein ChemistryGenentech Jun 2014 - Jan 2015South San Francisco, California, UsDeveloped novel bispecific polymer-antibody conjugates using different chemical cross-linkers. Established conjugation, purification (AKTA systems), and characterization methods with liquid chromatography, gel electrophoresis, and mass spectrometry
Lu Dai Skills
Lu Dai Education Details
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Regulatory Affairs Professionals Society (Raps)Regulatory Affairs Certificate: Pharmaceuticals -
Indiana University BloomingtonChemistry
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University Of Science And Technology Of ChinaChemistry
Frequently Asked Questions about Lu Dai
What is Lu Dai's role at the current company?
Lu Dai's current role is Quality | Analytical Development.
What is Lu Dai's email address?
Lu Dai's email address is da****@****ene.com
What schools did Lu Dai attend?
Lu Dai attended Regulatory Affairs Professionals Society (Raps), Indiana University Bloomington, University Of Science And Technology Of China.
What are some of Lu Dai's interests?
Lu Dai has interest in Cooking, Drumming, Travelling, Yoga, Outdoors, Hiking, Fencing.
What skills is Lu Dai known for?
Lu Dai has skills like Uv/vis, Hplc, Nmr, Tem, Mass Spectrometry, Afm, Gel Electrophoresis, Fib, Lc Ms, Fplc, Confocal Microscopy, Gas Chromatography.
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