Diane Rossi
I am a detail-oriented biopharmaceutical professional with excellent critical-thinking and problem-solving skills with extensive experience in the Biotechnology field
Research Expertise
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Education
College of Saint Elizabeth
B.S., Biology / May, 1997
Rutgers, The State University of New Jersey
M.S., Biomedical Sciences / February, 2010
Experience
Gilead Sciences/Immunomedics, Inc.
Manager, Cell Culture Production, Upstream Manufacturing / June, 2019 — March, 2023
Responsible for performing/supervising cell culture maintenance and media/supplement preparation for cGMP manufacturing while practicing strong aseptic technique Responsible for generating and revising batch records, SOPs and other cGMP documents as necessary Directly supervise two upstream manufacturing specialists and 2 manufacturing scientists Report to Director of Upstream Manufacturing Represented Upstream Manufacturing as Seed Lab SME during 2 FDA Inspections and ultimate FDA approval
Senior Scientist II, Cell Culture Production, Upstream Manufacturing / June, 2016 — June, 2019
Responsible for performing/supervising cell culture maintenance and media/supplement preparation for cGMP manufacturing while practicing strong aseptic technique Responsible for generating and revising batch records, SOPs and other cGMP documents as necessary
Senior Scientist II, Preclinical Development / July, 2013 — May, 2016
Design, perform and analyzes cell-based assays to determine in vitro functional characterization and mechanism of action of monoclonal antibodies, which includes conducting CDC, ADCC, cell signaling (e.g., Western blots, etc.), apoptosis, and anti-proliferative analyses (e.g., MTS, etc.) Processing of human blood (e.g., isolation of T cell subsets, etc.) from blood banks and in-house donors for use in cell-based assays (e.g., T-cell redirecting assays, ADCC, etc.) Multicolor FACs analysis Manuscript preparation and associated publications Report to Director of Preclinical Development
Senior Scientist, Research & Development / July, 2006 — July, 2013
Design of expression vectors for production of novel recombinant proteins Development of strategies for the production, purification, biochemical characterization and evaluation of biological activity Cell line and assay development Manuscript preparation and associated publications Presentation of results at scientific meetings Report to VP of R&D
Scientist, Research & Development / October, 2005 — June, 2006
Construction of humanized antibody staging and expression vectors for the production of novel recombinant proteins Transfection of humanized expression vectors using mammalian expression system Selection, screening, subcloning and amplification of stable antibody producing cell lines Antibody purification and characterization (BIAcore, HPLC, SDS-PAGE, Western Blot, etc.) Cell based assays (ADCC, MTT, etc.) Development and characterization of novel mammalian host cell line Design and perform experiments such as in vitro assays and optimization of purification procedures Lead in bench-scale bioreactor experiments for medium development, cell line screening and cell culture process development Report to VP of R&D
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