Devi Visone, M.S. Email and Phone Number
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25+ year biotechnology industry professional with broad experience spanning all stages of development, from pre-IND through commercialization (BLA for RecothromTM; approved in 2008). Completed a Master of Science in Biomedical Regulatory Affairs (June 2012) at the University of Washington. Recognized for attention to detail and effectiveness, both in technical writing and data-centric presentations; a self-directed, results-oriented leader and problem solver who moves individual and team projects from inception to completion, pro-actively producing high quality results.Specialties: • Master of Science, Biomedical Regulatory Affairs, University of Washington (June 2012)• Biomedical Regulatory Affairs Certificate, University of Washington (June 2010)• Clinical Trials Certificate, University of Washington (June 2011)• Biotech Project Management Classes, University of Washington• HPLC (all separation modes), iCIEF, CE-SDS• LC-MS/MS (glycan and peptide mapping analyses)• Circular Dichroism, Differential Scanning Calorimetry, Fluorescence, FTIR• Technical Writing, Statistics, cGMPs
Mapp Biopharmaceutical Inc
View- Website:
- mappbio.com
- Employees:
- 69
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Senior Director, Analytical DevelopmentMapp Biopharmaceutical IncEdmonds, Wa, Us
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Director, Analytical DevelopmentMapp Biopharmaceutical Inc Feb 2019 - PresentSan Diego, California, Us
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Scientist, Bioprocess SciencesSound Biologics (Qilu Puget Sound Biotherapeutics) Jun 2017 - Feb 2019
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ScientistBristol-Myers Squibb Jun 2015 - Jun 2017Lawrence Township, Nj, UsDeveloped release and stability assays for biologics in the development pipeline.Led instrument qualification initiative for a cross-functional team.Transferred and co-qualified methods to BMS QC and external CMO.Supervised contractor to develop release and stability methods. -
Senior Scientist, Group LeaderEurofins Lancaster Laboratories Feb 2015 - Jun 2015Lancaster, Pa, Us--Work as contractor at Zymo/BMS (Seattle, WA) performing development of release and stability HPLC/UPLC and CE assays for biologics in development pipeline. -
Group Leader, Senior ScientistEurofins Lancaster Laboratories Jun 2012 - Feb 2015Lancaster, Pa, Us--Promoted to Group Leader (Aug 2014); responsible for supervising 6 Eurofins Lancaster staff in the Analytical Sciences group at Amgen.--Work as contractor at Amgen (Seattle, WA) performing analytical characterization (LC-MS/MS; glycan and peptide mapping analyses), supporting the Biosimilars program. Specific accomplishments include: optimized UPLC HILIC characterization method for N-linked glycan analysis of antibody molecules; collaborated in authoring technical protocol, characterization, and development reports for UPLC HILIC method; and developed fluorescent peptide map method for rapid detection of a sequence variant, supporting the Biosimilar program.
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Part-Time Faculty, Science DivisionShoreline Community College Jun 2009 - Jun 2012Shoreline, Washington, UsInstructor for general inorganic chemistry lab-lecture courses (as part of year-long general chemistry series). Delivered weekly lectures explaining experimental theories, procedures, and data analysis; performed in-class experimental demonstrations; led weekly laboratory classes, ensuring students understood, completed, and appropriately documented (in laboratory notebook, laboratory report) experimental work; regularly delivered quizzes and exams; and graded all course-related assignments per established protocols. -
ScientistZymogenetics Nov 2002 - Jun 2009Seattle, Washington, UsCollaborated in team setting to support characterization, analytical and formulation development for critical path projects in development pipeline. Regularly delivered effective data presentations at several cross-departmental meetings and to senior management, as well as authored reports and generated data for incorporation into regulatory filings (IND, BLA, and PAS). -
Associate Scientist IiBiogen Mar 2001 - Oct 2002Cambridge, Ma, UsPharmaceutical Science and Technology department (Mar 2001 to Nov 2002): Collaborated in team setting to support pre-formulation and formulation efforts for products in development pipeline (typically four, concurrently). Conducted biophysical characterization of proteins by Differential Scanning Calorimetry and Fluorescence, performed lyophilized and liquid formulation development, produced GLP preclinical material, and conducted conditions-of-use/compatibility studies, supporting preclinical and clinical activities. -
Associate Scientist IiBiogen Nov 1997 - Mar 2001Cambridge, Ma, UsAnalytical Development and Quality Control department: provided analytical development, method transfer, and analytical support for products in development pipeline. Developed, qualified, and performed Size-Exclusion HPLC, Protein A HPLC, 2-AA carbohydrate HPLC, AccQTag (amino acid analysis), peptide mapping, SDS-PAGE, and ELISA assays, supporting development. Responsibilities also included conducting weekly GLP training sessions (years of 1999 and 2000) and regular laboratory audits to ensure compliance with appropriate regulatory standards.
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Senior Research AssistantImmunex Jun 1994 - Oct 1997UsAs part of the Analytical Chemistry and Formulation department, conducted pre-formulation, formulation, and analytical development support for products in development, utilizing several analytical techniques: SDS-PAGE, HPLC, Differential Scanning Calorimetry, Fourier Transform Infrared Spectroscopy, UV/Vis, Western, Dot Blot (product identification), and Light Scattering.
Devi Visone, M.S. Skills
Devi Visone, M.S. Education Details
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University Of WashingtonBiomedical Regulatory Affairs -
University Of WashingtonBiomedical Regulatory Affairs
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University Of WashingtonBiochemistry
Frequently Asked Questions about Devi Visone, M.S.
What company does Devi Visone, M.S. work for?
Devi Visone, M.S. works for Mapp Biopharmaceutical Inc
What is Devi Visone, M.S.'s role at the current company?
Devi Visone, M.S.'s current role is Senior Director, Analytical Development.
What is Devi Visone, M.S.'s email address?
Devi Visone, M.S.'s email address is de****@****one.net
What is Devi Visone, M.S.'s direct phone number?
Devi Visone, M.S.'s direct phone number is (212) 546*****
What schools did Devi Visone, M.S. attend?
Devi Visone, M.S. attended University Of Washington, University Of Washington, University Of Washington.
What skills is Devi Visone, M.S. known for?
Devi Visone, M.S. has skills like Hplc, Biotechnology, Protein Chemistry, Glp, Chromatography, Gmp, Life Sciences, Chemistry, Regulatory Affairs, Analytical Chemistry, Elisa, Laboratory.
Who are Devi Visone, M.S.'s colleagues?
Devi Visone, M.S.'s colleagues are Brent Y., Kelly Mcallister, Ellen Monson, Margaret T. Elorza, Phd, Jenni Gorospe, James Logue, Amanda S..
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