Andreea Neaga

About Andreea Neaga

Dynamic associate director with strong record of providing scientific leadership while driving GLP-regulated immunologic evaluation and large molecule bioanalysis. Proven ability to develop scientific teams while instilling a high degree of ownership and accountability through performance driven management. Demonstrated record of high customer engagement and retention through consulting, business development and project execution functions. Expertise in designing IND-enabling packages, consulting, developing and providing immunology and bioanalytical strategy and support for non-clinical and global clinical programs (US FDA, Korean FDA, EMA). Can make major contributions quickly through: • Leading teams and building organizational capability• Demonstrated ability to lead change and create a culture of engagement • Effectively communicating with internal and external customers• Increasing efficiency and accountability through process improvement, root cause analysis and CAPA implementation• Adapting to changing industry, customer and project requirements• Applying state-of-the-art expertise of immunologic assays (ELISA, MSD, Gyrolab, Luminex, cell-based functional assays, flow cytometry) to preclinical and clinical drug developmentSpecialties: Protein expression and purification via column chromatography and HPLC/FPLC. Performed cloning, site-directed mutagenesis, bacterial transformation, transfection, plate-based binding assays and fluorescence polarization assays. Designed and developed cell-based assays, as well as biotherapeutic-specific ligand binding assays for PK and immunogenicity analysis.

Experience

1. Associate Director Study Setup, Technical Teams & Training

   Labcorp

   Jun 2021 — Present

Education

• University of Michigan

  B.S., Biological Chemistry

  1998 — 2002

• Case Western Reserve University

  M.S., Immunology

  2005 — 2008

• Western Michigan University - Haworth College of Business

  MBA, Business Administration

  2009 — 2012

Skills

• Elisa
• Glp
• U.s. Food and Drug Administration (Fda)
• Protein Chemistry
• Standard Operating Procedure (Sop)
• Antibodies
• Immunoassays
• Cell Biology
• Cell
• Biotechnology
• In Vitro
• Monoclonal Antibodies
• Assay Development
• Cell Based Assays
• Life Sciences
• Western Blotting
• Drug Development
• Fda
• Bioanalysis
• Purification
• Good Laboratory Practice (Glp)
• Project Management