Seraphin Kuate

Associate Director, Global Lead Cmc Regulatory Affairs, Biologics

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Location:

5800 Park Of Commerce Blvd northwest, Boca Raton, FL 33487

Industry:

Pharmaceuticals

Work:

Boehringer Ingelheim
Associate Director, Global Lead Cmc Regulatory Affairs, Biologics
Oncobiologics Inc. Sep 1, 2015 - Sep 2017
Associate Director, Regulatory Affairs Cmc - Biosimilars Product Development
Biotest Pharmaceuticals Corporation Nov 2012 - Sep 2015
Manager Clinical and Cmc Regulatory Affairs, Biologics
University of Maryland University College Nov 2012 - Sep 2015
Adjunct Associate Professor, Global Regulatory Affairs
Fda Oct 2010 - Nov 2012
Cmc Reviewer Gene Therapy Products

Education:

University of Maryland Global Campus 2011
Master of Business Administration, Masters, Business Administration, Management, Marketing, Finance, Business Administration and Management Bielefeld University 2007
Masters, Master of Arts, Epidemiology Ruhr University Bochum 2002
Doctorates, Doctor of Philosophy, Molecular Biology, Immunology, Virology, Microbiology, Philosophy Universit De Yaound I 1996
Masters, Biochemistry

Skills:

Biotechnology
Regulatory Affairs
Vaccines
Fda
Immunology
Molecular Biology
Regulatory Submissions
Virology
Gmp
Cell
In Vitro
Scientific Writing
Biologics
Biochemistry
Drug Development
Gene Therapy
In Vivo
Microbiology
Cell Culture
U.s. Food and Drug Administration
International Business Management
Sop Development
Lifesciences
Business Strategy
Strategic Planning
Marketing Strategy
Strategic Financial Planning
Cta
Cancer Research
Elisa
Swot Analysis
Bla
Pre Ind and Ind
Monoclonal Antibodies
Epidemiology/Biostatistics
Genetics
Flow Cytometry
Cell Biology
Biopharmaceuticals

Interests:

Clinical and Regulatory Affairs
Quality Assurance and Quality Management
Clinical Research
Strategic Planning and Management
Regulatory Affairs
Regulatory Strategy
Strategic Management
Strategic Planning
Cmc Regulatory Compliance Strategy
Regulatory Compliance

Languages:

English
French
German

Certifications:

Rac (Us)
Ccrp (Link)
Regulatory Affairs Professionals Society (Raps)
The Society of Clinical Research Associates (Socra)
Ccrp

Seraphin Kuate

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Location:

Montgomery, NY

Seraphin Kuate Bethesda, MD

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Work:

Center of Biologics Evaluation and Research

2010 to 2000
Commissioner's fellow National Cancer Institute

2007 to 2010
Postdoctoral fellow University of Bielefeld, Bielefeld, Germany

2005 to 2008
Graduate student Ruhr University Bochum (RUB), Bochum, Germany

2002 to 2007
Postdoctoral research fellow Immunology

1999 to 2002
PHD student, Molecular Virology West Province

1996 to 1999
Graduate research assistant, University Teaching Hospital, Yaound, Cameroon

Education:

University of Maryland University College
Adelphi, MD
2011
MSc in Management University of Bielefeld
2008
MSc in Epidemiology Ruhr University Bochum
Bochum
Jan 1999 to Jan 2002
PhD in Molecular Virology / Immunology Uninversity of Yaounde I
Yaound
Jan 1991 to Jan 1996
MS in Biochemistry

Skills:

- Hand-on Training as CMC reviewer for clinical protocols using biologics products