Ronna Dornsife

About Ronna Dornsife

Cell Biologist with viral vector manufacturing and bioprocessing, plus aseptic cell culture, single-use bioreactor and analytical assay development experience, including implementation and training for new equipment, instrumentation, or processes, and development of novel and/or functional cell-or immune-based assays. Experience includes extensive flow cytometry, cell therapy, as well as AAV viral vector production and characterization skills, plus upstream and downstream, bioprocessing knowledge and hands-on skills.• 3 years of gene therapy (AAV) manufacturing and analytics experience (Sf9 insect cell/baculovirus and HEK293 triple transfection), including gp64 flow cytometry assay for baculovirus titers and flow cytometry-based transduction (titer/potency assay with HT1080 cells). Development and delivery of lectures and hands on laboratory training for undergraduates on Sf9 insect cell production of AAV2-GFP.• 4 years of cell therapy development skills, including validation of new potency assays and qualification of automated cell processing equipment/software (Sepax) plus cartridge-based, endotoxin testing (Charles River). Site Leader for international study to qualify new clinical-flow cytometry CD34+ stem cell assay product (as compared to existing predicate method on market). Data from these studies used for successful BLA for Duke Cord Blood Stem cell product. Assembly of CMC documentation, team representative for cGMP cell therapy manufacturing facility construction project, plus tech transfer and training of cGMP, clinical manufacturing personnel.• Advanced flow cytometry experience (20+ years) including multicolor-panel design and data analyses skills (immunology, vaccine studies), designing automated-batch, flow data analysis layouts (FCS Express), and authoring SOPs and training others on flow cytometry methods and data analysis.• 20+ years of experience with primary human cells (lymphocytes, hematopoietic stem or progenitors, mesenchymal stem cells). Flow cytometry instrument validation, assay qualification, antibody titer studies to select optimal/economical concentration, author SOPs. Past formal supervisor of small teams (2-4).• 20+ years of cell-based and virus-based assay development skills and execution, success-based confidence to deliver novel methods, plan and execute CMC activities, and collaborate with multi-disciplinary colleagues. Enthusiasm to train and mentor trainees or reports with articulate verbal and written communication skills and engaging training delivery style

Experience

1. Manager, Upstream Team, Pre-clinical Manufacturing Viral Vectors (Gene Therapy)

   AskBio Inc.

   Mar 2023 — Present · Research Triangle Park, NC, US

   Lead team (5-6) in both upstream and downstream, pre-clinical manufacturing of viral vectors for proposed gene therapy treatments or cures. Contribute to pre-clinical manufacturing team with hands on upstream and downstream, hands-on production of viral vectors. Champion new production efficiencies and operational updates to meet team goals and support team members\' successes.

Education

• The Ohio State University

  Bachelor of Science - BS, Genetics

• Colorado State University

  Master of Science - MS, Pathology/Experimental Pathology

Skills

• Cell Biology
• Flow Cytometry
• In Vitro
• Stem Cells
• Assay Development
• Tissue Culture
• Cell Culture
• Biotechnology
• Biopharmaceuticals
• Cell
• Molecular Biology
• Fluorescence Microscopy
• Signal Transduction
• In Vivo
• Life Sciences
• Cancer Research
• Regenerative Medicine
• Cell Therapy
• Nanobiotechnology
• Western Blotting
• Immunology
• Elisa
• Laboratory
• Biopharma
• Cell-Based Assays
• Anti-Inflammatory Research
• Flowjo Flow Data Analysis
• Anti-Angiogenesis
• Cd34+ Flow Cytometry
• Fcs Express Flow Data Analysis
• Phosphoproteins
• Laboratory Skills
• Bioreactor
• Metabolics
• Stem Cell Research
• Biochemistry
• Oncology
• Antibodies