Yemin X.
About Yemin X.
Yemin X. is an Associate Director, Regulatory CMC at Bristol Myers Squibb and works in CMC Regulatory, Global Development at Regeneron, with extensive experience in biopharmaceuticals and regulatory affairs.
Current Title and Roles
Yemin X. presently holds dual roles within the biopharmaceutical industry. At Bristol Myers Squibb, Yemin serves as Associate Director, Regulatory CMC. Simultaneously, Yemin is involved with Regeneron in the CMC Regulatory, Global Development division. These positions underscore Yemin's extensive expertise in regulatory affairs and CMC (Chemistry, Manufacturing, and Controls) within the sector.
Professional Experience
Yemin X. has garnered vast experience across various reputable organizations. At Bristol Myers Squibb, Yemin advanced from a Scientist (2014-2017) to serve as Analytical Team Lead (2015-2017). Prior engagements include serving as a Research Assistant at the University of Colorado at Boulder from 2009 to 2014, and as a Teaching Assistant from 2008 to 2009. These roles have facilitated Yemin's proficiency in CMC strategies, Quality by Design (QbD) principles, and regulatory submissions.
Expertise and Technical Skills
Yemin X. has developed a significant skill set in biopharmaceutical processes. This includes an in-depth understanding of Quality by Design (QbD) principles, protein fermentation, purification, and characterization. Yemin is also skilled in advanced aseptic processing technology and has expertise in therapeutic protein formulation design, aqueous protein stability, lyophilization process design, and strategies for increasing protein solubility, stability, and bioavailability.
Contributions and CMC Strategies
Yemin X. has actively contributed to the fast-to-first-in-human (FIH) approach, IND/BLA authoring, and responses to health authority inquiries. Yemin has also developed comprehensive CMC strategies for stability and release testing, and control strategies for manufacturing drug substances (DS) and drug products (DP). Yemin plays a crucial role in transferring processes and analytical methods to CMOs, CROs, and commercial sites.
Language Proficiency
Yemin X. is fluent in both English and Mandarin Chinese. This bilinguistic capability enables Yemin to navigate and communicate effectively in diverse professional and cultural environments, further broadening the scope of collaborative and regulatory opportunities.