Xiao Cui
Senior Scientist at Celgene | East Brunswick, New Jersey, United States
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Xiao Cui is a Senior Scientist at Celgene, where she leverages over 14 years of extensive experience in FDA and CFDA regulated environments to drive innovative solutions in analytical development. Known for her consistent work ethic and meticulous attention to detail, Xiao has built a strong reputation for her ability to plan, lead, and execute complex projects while adhering to current good manufacturing practices (cGMPs). Her expertise spans a range of critical areas, including pharmaceutics, analytical method validation, and regulatory submissions, making her an invaluable asset to the organization.
In her current role, Xiao has successfully supported the New Drug Application (NDA) filing for the Extended Release Delivery System. She independently designed and conducted multiple analytical activities under tight timelines, showcasing her exceptional problem-solving skills and ability to deliver results under pressure. Her proactive approach has led to the implementation of several initiatives aimed at expanding the analytical development (AD) capabilities, enhancing project support efficiency across the board.
Xiao’s proficiency in developing analytical methods and validating them for fixed dosage combination products has positioned her as a key contributor to Celgene’s mission of advancing healthcare solutions. She is well-versed in the Common Technical Document (CTD) format, ensuring that all regulatory submissions meet stringent industry standards. With a focus on continuous improvement, Xiao remains committed to refining methodologies and performing scientific tasks that drive innovation and compliance within the pharmaceutical landscape. Her dedication to excellence and collaborative spirit make her a respected leader in the field of analytical development.
Senior Scientist at Celgene in September 2016 to Present
Scientist at Bristol-Myers Squibb,Global Analytical Technology (Commercial) in April 2015 to September 2016
Group Leader at Primera Analytical Solution,Corp in January 2012 to April 2015
Scientist at Tris Pharma in August 2010 to January 2012
Senior Scientist at Shenyang Hongqi Pharmaceutical Co., Ltd. in September 2006 to October 2009
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Jiamusi University, Bachelor's degree, November 2026
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HPLC
Pharmaceutics
UV/Vis
Pharmaceutical Industry
Validation
Formulation
U.S. Food and Drug Administration (FDA)
Project Management
Dissolution
ICP-MS
Abbreviated New Drug Application (ANDA)
Deviations
Analytical Method Validation
ANVISA
New Drug Application (NDA)
Common Technical Document (CTD)
Fixed Dosage Combination product
Analytical Chemistry
Chromatography
Analytical Methods Development
Standard Operating Procedure (SOP)
Regulatory Submissions
Manufacturing
ICH
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Discover more about CelgeneWhat is Xiao Cui email address?
Email Xiao Cui at [email protected]. This email is the most updated Xiao Cui's email found in 2026.
What is Xiao Cui phone number?
Xiao Cui phone number is 7327894052.
How to contact Xiao Cui?
To contact Xiao Cui send an email to [email protected]. If you want to call Xiao Cui try calling on 7327894052. (updated on September 03, 2024)
What company does Xiao Cui work for?
Xiao Cui works for Celgene
What is Xiao Cui's role at Celgene?
Xiao Cui is Senior Scientist
What industry does Xiao Cui work in?
Xiao Cui works in the Pharmaceuticals industry.
Xiao Cui Email Addresses
Xiao Cui Phone Numbers
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