Seraphin Kuate
Global CMC Regulatory Professional, Biologics, Biosimilars, Gene/Cell Therapy
- Role
- Director Global Cmc Regulatory, Car t Cell Therapy at Bristol Myers Squibb
- Location
- Montgomery, NY, US
- LinkedIn followers
- 500 followers
About Seraphin Kuate
25+ years of combined experience in biotechnology research and global regulatory affairs, including 15+ years of experience in Global Regulatory CMC as CMC reviewer for cell/gene therapy products at US FDA and as Regulatory CMC professional at different biopharmaceutical companies- Expertise in biologics and biotechnology-based products development, including Cell/Gene Therapy, new Biologics Entities (NBEs), and Biosimilars products- Professional Certifications: Regulatory Affairs Professional (RAC US, RAPS) and Certified Clinical Research Professional (CCRP, SoCRA)- Experience in Global Regulatory Affairs with international regulatory submission experience- Experienced US representative for international regulatory submissions- Teaching experience in Global Regulatory Affairs
Experience
Director Global Cmc Regulatory, Car t Cell Therapy
Aug 2020 — Present · US
CAR-T Cell Therapy, Lentiviral vectors
Education
University of Yaounde I, Cameroon
Master’s Degree, Biochemistry
1996
University of Maryland Global Campus
Master of Business Administration (MBA), Business Administration and Management, General
2013
Bielefeld University
Master's Degree, Epidemiology/Biostatsistics
2007
Ruhr University Bochum
Doctor of Philosophy (Ph.D.), Molecular Biology / Virology / Immunology
2002
University of Maryland Global Campus
Master’s Degree, International Management (MIM) - Finance, Enterprise & Marketing Management
2011
Skills
- Genetics
- Business Strategy
- Cell Culture
- Elisa
- Cell Biology
- Fda
- Biotechnology
- Virology
- Cta
- Strategic Financial Planning
- Biologics
- Regulatory Affairs
- Lifesciences
- Drug Development
- Biopharmaceuticals
- U.s. Food and Drug Administration (Fda)
- Bla
- Biochemistry
- Monoclonal Antibodies
- Strategic Planning
- Immunology
- Molecular Biology
- Flow Cytometry
- In Vitro
- Sop Development
- Epidemiology/Biostatistics
- Cell
- Scientific Writing
- Vaccines
- Regulatory Submissions
- International Business Management
- In Vivo
- Swot Analysis
- Gene Therapy
- Pre-Ind and Ind
- Cancer Research
- Marketing Strategy
- Gmp
- Microbiology
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