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

Cancer Research
Oncology
Immunology and Allergy
Immunology
Cell Biology
Hematology
Biochemistry
Biotechnology
Pharmacology
Biomedical Engineering
Organic Chemistry
Pharmaceutical Science
Bioengineering

About

**I am a detail-oriented biopharmaceutical professional with excellent critical-thinking and problem-solving skills with extensive experience in the Biotechnology field. I was actively involved in many successful biopharmaceutical drug development projects, preclinical research, commercial manufacturing, FDA inspections and ultimately achieving FDA approval of the triple-negative breast cancer drug TRODELVY®**

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Publications

IMMU-140, a Novel SN-38 Antibody–Drug Conjugate Targeting HLA-DR, Mediates Dual Cytotoxic Effects in Hematologic Cancers and Malignant Melanoma
Molecular Cancer Therapeutics
2018
Combination Therapy with Bispecific Antibodies and PD-1 Blockade Enhances the Antitumor Potency of T Cells
Cancer Research
2017
Synthetic Lethality Exploitation by an Anti–Trop-2-SN-38 Antibody–Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2–wild-type Triple-Negative Breast Cancer
Clinical Cancer Research
2017
Redirected T-Cell Killing of Solid Cancers Targeted with an Anti-CD3/Trop-2–Bispecific Antibody Is Enhanced in Combination with Interferon-α
Molecular Cancer Therapeutics
2014
A new class of bispecific antibodies to redirect T cells for cancer immunotherapy
mAbs
2013
Trogocytosis of multiple B-cell surface markers by CD22 targeting with epratuzumab
Blood
2013
Evaluation of a Novel Hexavalent Humanized Anti-IGF-1R Antibody and Its Bivalent Parental IgG in Diverse Cancer Cell Lines
PLoS ONE
2012
A new mammalian host cell with enhanced survival enables completely serum‐free development of high‐level protein production cell lines
Biotechnology Progress
2011
A Bispecific Antibody-IFNα2b Immunocytokine Targeting CD20 and HLA-DR Is Highly Toxic to Human Lymphoma and Multiple Myeloma Cells
Cancer Research
2010
A New Method to Produce MonoPEGylated Dimeric Cytokines Shown with Human Interferon-α2b
Bioconjugate Chemistry
2009
Preclinical studies on targeted delivery of multiple IFNα2b to HLA-DR in diverse hematologic cancers
Blood
2011
Predictive biomarkers for sacituzumab govitecan efficacy in Trop-2-expressing triple-negative breast cancer
Oncotarget
2020

Education

College of Saint Elizabeth

B.S., Biology / May, 1997

Morristown, New Jersey, United States of America

Rutgers, The State University of New Jersey

M.S., Biomedical Sciences / February, 2010

Newark, New Jersey, United States of America

Experience

Gilead Sciences/Immunomedics, Inc.

Manager, Cell Culture Production, Upstream Manufacturing / June, 2019March, 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, 2016June, 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, 2013May, 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, 2006July, 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, 2005June, 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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