Senior Director
CurrentHead of the External Manufacturing and MSAT team for allogeneic manufacturing of corneal cells.
Aug 2023 - Present
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Lan Le Email & Phone Number
Senior Director at Aurion Biotech
at
Aurion Biotech
1 work email found
@bms.com
2 phones found area 713
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Director at Aurion Biotech
Location
Seattle, Washington, United States
Who is Lan Le? Overview
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Quick answer
Lan Le is listed as Senior Director at Aurion Biotech at Aurion Biotech, based in Seattle, Washington, United States. AeroLeads shows a work email signal at bms.com, phone signal with area code 713, and a matched LinkedIn profile for Lan Le.
Lan Le previously worked as Senior Director at Aurion Biotech and Director at Bristol Myers Squibb. Lan Le holds Bs, Biomedical Engineering from The Johns Hopkins University.
Company email context
Email format at Aurion Biotech
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{first}.{last}@bms.com
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Profile bio
About Lan Le
Scientist, Engineer, and People Leader | Cell Therapy & Biologics | MS&T | Formulation/Process DevelopmentWith 15+ years of experience in MS&T and formulation/process development, I am a technical professional specializing in the manufacture of cell therapies and biologics, including bispecifics, mAbs, and ADCs. Currently, I serve as an individual contributor, matrixed team lead for a commercial cell therapy product, overseeing production, delivery, LCM changes, improvements, and supply expansion.The promise of autologous cell therapy and its one-lot-per-patient scale-out model captivate me, emphasizing the significance of CMC (Chemistry, Manufacturing, and Controls). Throughout my career, I have acquired extensive knowledge in cell therapy manufacturing processes, successfully led tech transfers to CMOs, and managed teams for cell therapy introduction in clinics and commercial markets (US/EU/JP). This includes tactical execution, validation strategies for PPQ, root cause analyses, and overseeing teams of up to 13 FTE.With a robust track record in regulatory affairs, I have authored CMC sections for IND/CTA submissions, covering facilities, molecule characterization, stability, drug delivery, and control systems in biologics. I have navigated Health Authority meetings and adeptly responded to information requests / regulatory queries from FDA/PMDA/EMA for submissions in Cell Therapy.Previously at Genentech, I found fulfillment in providing medicines for unmet medical needs. After a two-year sabbatical exploring the world, I re-entered the biotech workforce in Seattle's vibrant community. In my prior role at a start-up, I embraced versatility, leading Formulation/Downstream Processing (UFDF) development, managing RFQs for CMOs, reviewing batch records and deviations, and spearheading tech transfers. I devised an innovative logistics strategy for DS/DP transportation and successfully influenced its implementation.Fuelled by a passion for continuous learning, product improvements, and deep technical understanding, I have authored manuscripts, delivered presentations, and secured patents. My experience includes development studies using DOE, long-term GMP stability support, TT to CMOs, and alignment facilitation across management and cross-functional teams.
Listed skills include Biotechnology, Hplc, Protein Chemistry, Glp, and 39 others.
Current workplace
Lan Le's current company
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16 roles
Lan Le work experience
A career timeline built from the work history available for this profile.
Director
Breyanzi TPT Lead managing matrixed team for commercial technical BoW.
Oct 2022 - Aug 2023
Associate Director
Tech Transfer team manager for cell therapy transfers to CMOs across multiple regions.
Jun 2021 - Nov 2022
Interim External Tt Team Manager
Interim Tech Transfer team manager for cell therapy transfers to CMOs.
Jan 2021 - Jun 2021
Principal Engineer
Product Stewardship: technical SME of late stage cell therapy product and process control strategy owner.
Jul 2020 - Jun 2021
Senior Process Engineer
• Led successful tech transfer of Liso-cel T-cell Selection to Japan CMO through to PPQ execution and PLI readiness• Led low viabilities apheresis investigation and designed experiments for RCA• Owned, authored, and drove to completion change controls
Mar 2019 - Jul 2020
Scientist
• Formulation lead for all liquid bispecific proteins for IV administration using DOE• Lead RFQs for Fill/Finish (FF) CMO, PIP in DS/DP CMOs, and assist Quality with technical BR review and deviations for on-time batch releases • CMO Tech Transfer lead for UFDF, all analytical assays, and method qualifications for DS manufacture and DP FF• Develop tech transfer and DP stability strategy for bispecific proteins from DS manufacture to shipment to clinical sites
Sep 2017 - Mar 2019
Self Employed
Extended Sabbatical
• Personal financial planning allowed for an extended sabbatical to travel around the world• Passionate about financial security, which promotes indepence• Credit card Travel Hacking SME (subject matter expert) amongst friends and family
Apr 2015 - Sep 2017
Engineer Ii
Early Stage Pharmaceutical Development• Lead author for formulation CMC sections of an antibody drug conjugate Investigative New Drug (IND) submission• Design, execute and analyze experiments and communicate results to CMC/TDT teams• Led process development and formulation of topical gel product, including CRO trainings, and CMO selection and tech transfer
Aug 2013 - Apr 2015
Engineer I
Early Stage Pharmaceutical Development• Lead in formulation development for an ADC• Designed and executed dose solution experiments in GLP environment• Conducted experiments to support GLP toxicology studies at CROs
Dec 2012 - Aug 2013
Research Associate
Early Stage Pharmaceutical Development• Supported formulation development for ADCs and high concentration IgG1 antibody• Ensured stability of molecules in formulations using HPLC (SEC, HIC, RP), CE-SDS, icIEF for characterization
Dec 2010 - Dec 2012
Research Assistant
Early Stage Pharmaceutical Development• Developed and supported formulation development for multiple projects• Presented data at CMC/TDT teams
Sep 2009 - Dec 2010
Late Stage Pharmaceutical Development
Late Stage Pharmaceutical Development• Research exploring the effects of various surfaces, protein concentrations, and formulation buffers on protein stability
Jan 2009 - Sep 2009
Scientist
Intelligent Substrates, Inc
Since ISI is a start-up company, responsibilities ranged from development of the company to research and development of the new technology used to create custom patterns on cellular substrates in terms of parameterization, programming, definition of system capabilities, etc.
Feb 2008 - Jan 2009
Process Development Engineer
Intern in the Process Development branch of the Research and Development Department. Worked in a FDA regulated pharmaceutical company and learned the entire process of formulation, scale-up, and commercialization of transdermal patches. Responsible for a project involving an innovative product.
Jun 2007 - Aug 2007
Researcher
Jun 2005 - May 2007
3 education records
Lan Le education
Bs, Biomedical Engineering
The Johns Hopkins University
Mse, Mechanical Engineering
The Johns Hopkins University
Certificate In Leadership And Management
Uc Berkeley Extension
FAQ
Frequently asked questions about Lan Le
Quick answers generated from the profile data available on this page.
What company does Lan Le work for?
Lan Le works for Aurion Biotech.
What is Lan Le's role at Aurion Biotech?
Lan Le is listed as Senior Director at Aurion Biotech at Aurion Biotech.
What is Lan Le's email address?
AeroLeads has found 1 work email signal at @bms.com for Lan Le at Aurion Biotech.
What is Lan Le's phone number?
AeroLeads has found 2 phone signal(s) with area code 713 for Lan Le at Aurion Biotech.
Where is Lan Le based?
Lan Le is based in Seattle, Washington, United States while working with Aurion Biotech.
What companies has Lan Le worked for?
Lan Le has worked for Aurion Biotech, Bristol Myers Squibb, Juno Therapeutics, Inc., Aptevo Therapeutics Inc, and Extended Sabbatical.
How can I contact Lan Le?
You can use AeroLeads to view verified contact signals for Lan Le at Aurion Biotech, including work email, phone, and LinkedIn data when available.
What schools did Lan Le attend?
Lan Le holds Bs, Biomedical Engineering from The Johns Hopkins University.
What skills is Lan Le known for?
Lan Le is listed with skills including Biotechnology, Hplc, Protein Chemistry, Glp, Formulation, Molecular Biology, Antibodies, and Biomedical Engineering.
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