Lienhanh N
Principal Consultant at Microbe SME LLC | United States
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Lien-hanh N. currently serves as a Principal Consultant at Microbe SME LLC, where she leverages over 25 years of extensive experience in microbiology to deliver strategic guidance and technical expertise to clients across the biotechnology, medical device, pharmaceutical, and vaccine sectors. In her role, she spearheads complex projects related to regulatory compliance, quality systems, and microbiological testing, ensuring that client operations meet stringent industry standards such as GLP and GMP. Lien-hanh’s expertise encompasses a broad spectrum of microbiological disciplines, including environmental monitoring, bacterial cell culture, and the development of monoclonal antibodies, which are critical to product safety and efficacy.
Her key projects often involve leading microbiological risk assessments, optimizing sterilization and contamination control processes, and supporting clients through IND submissions and regulatory audits. She has a proven track record of implementing robust microbiology programs aligned with regulatory expectations, utilizing tools like TrackWise for quality management and SOP development to streamline compliance workflows. Lien-hanh’s proactive approach and meticulous attention to detail have been instrumental in guiding clients through complex validation activities and ensuring adherence to environmental monitoring protocols.
As a technical leader, she is deeply committed to fostering a culture of quality and continuous improvement, often providing training and mentorship to microbiology teams. Her comprehensive understanding of microbiological testing, regulatory affairs, and quality systems positions her as a trusted advisor in navigating the evolving landscape of biotech and pharmaceutical manufacturing. Through her strategic insights and hands-on expertise, Lien-hanh N. continues to drive innovation and compliance excellence at Microbe SME LLC.
Principal Consultant at Microbe SME LLC in May 2021 to Present
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Drexel University, B.S.
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Quality Auditing
Bacterial Cell Culture
Change Management
Quality Management
Manufacturing Operations Management
Continuous Improvement
Consultation
Microbiology
LIMS
Biopharmaceuticals
GLP
FDA
Biotechnology
GMP
Aseptic Technique
Aseptic Processing
Sop
ELISA
Technology Transfer
Quality Control
Vaccines
Lifesciences
Change Control
CAPA
Pharmaceutical Industry
Virology
Assay Development
Validation
Purification
Immunoassays
HPLC
21 CFR Part 11
Protein Chemistry
Monoclonal Antibodies
Fermentation
Analytical Chemistry
V&V
Immunology
Chromatography
GxP
Cell Culture
SDS-PAGE
Drug Development
Laboratory
Protein Purification
IND
Regulatory Affairs
Quality System
TrackWise
Quality Assurance
Environmental Monitoring
Computer System Validation
SOP
Management
Clinical Trials
Medical Devices
Manufacturing
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What is Lien-hanh N email address?
Email Lien-hanh N at [email protected]. This email is the most updated Lien-hanh N's email found in 2026.
How to contact Lien-hanh N?
To contact Lien-hanh N send an email to [email protected]. (updated on May 03, 2025)
What company does Lienhanh N work for?
Lienhanh N works for Microbe SME LLC
What is Lienhanh N's role at Microbe SME LLC?
Lienhanh N is Principal Consultant
What is Lienhanh N's Phone Number?
Lienhanh N's phone (***) ***-*426
What industry does Lienhanh N work in?
Lienhanh N works in the Pharmaceuticals industry.
Lienhanh N Email Addresses
Lienhanh N Phone Numbers
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