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Lu Dai is listed as Quality | Analytical Development based in South San Francisco, California, United States. AeroLeads shows a work email signal at sana.com and a matched LinkedIn profile for Lu Dai.
Lu Dai previously worked as Senior Scientist, Quality Assurance at Sana Biotechnology, Inc. and Senior Scientist, Quality Control at Sana Biotechnology, Inc.. Lu Dai holds Regulatory Affairs Certificate: Pharmaceuticals from Regulatory Affairs Professionals Society (Raps).
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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.
Listed skills include Uv/Vis, Hplc, Nmr, Tem, and 33 others.
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Seattle, Washington, Us
Manage 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.
Seattle, 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.
Seattle, Washington, Us
South 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
South San Francisco, Ca, Us
Developed high-throughput purification and analysis of small molecule libraries using LC-MS, SFC-MS, and automated liquid handlers.
South San Francisco, California, Us
Developed 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
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Lu Dai is listed as Quality | Analytical Development.
AeroLeads has found 1 work email signal at @sana.com for Lu Dai.
Lu Dai is based in South San Francisco, California, United States.
Lu Dai has worked for Sana Biotechnology, Inc., Genentech, and Theravance Biopharma Us, Inc..
You can use AeroLeads to view verified contact signals for Lu Dai, including work email, phone, and LinkedIn data when available.
Lu Dai holds Regulatory Affairs Certificate: Pharmaceuticals from Regulatory Affairs Professionals Society (Raps).
Lu Dai is listed with skills including Uv/Vis, Hplc, Nmr, Tem, Mass Spectrometry, Afm, Gel Electrophoresis, and Fib.
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