Brooke Helfer

About Brooke Helfer

Over 15 years experience in the biotechnology industry working with cell biology, cellular therapeutics, biomarker and inflammation imaging, experimental design, and product development. Key SkillsTeam Leadership: Communicates at all levels, engages and motivates teams and collaborators, trains employees, leads client interactions, an organizer who builds trust.Research Scientist: Expertise in cell and molecular biology, cell therapy, assay development and validation.Effective Communicator: Able to convey complex scientific topics to technical and non-technical audiences.Technology Development & Evaluation: Leader of product translation with experience translating new technology from the academic lab into clinically applicable products; understanding of the drug development process.CMC: Develops technical regulatory documents and filings, manufacturing reports, and SOPs.Regulatory Consideration: Interaction with CBER and CDER, DMF generation and maintenance, IND filings and maintenance.Project Management: Communicates and manages research projects.

Experience

1. Senior Director of Product Development

   Bluesphere Bio

   Mar 2025 — Present

Education

• West Virginia University

  PhD, Cancer cell biology

  2004 — 2008

• Washington & Jefferson College

  Bachelor of Arts (BA), Cell/Cellular and Molecular Biology, German

  2000 — 2004

Skills

• Immunology
• Assay Development
• Transfection
• Dna
• Flow Cytometry
• Drug Discovery
• Tissue Culture
• In Vivo
• Elisa
• In Vitro
• Life Sciences
• Lifesciences
• Cell Biology
• Pcr
• Molecular Biology
• Fluorescence Microscopy
• Confocal Microscopy
• Cell Culture
• Biotechnology
• Stem Cells
• Facs
• Cancer Research
• Protein Chemistry
• Cell
• Proteomics
• Immunofluorescence
• Mammalian Cell Culture
• Fluorescence
• Rna Isolation
• Rt-Pcr
• Immunoassays