Experience

HUVEPHARMA, INC

• United States
• Veterinary Services
• 100 - 200 Employee

• Quality Control Manager

  • Jun 2002 - Present

  ∙ Maintain mammalian, insect, and avian tissue cultures ∙ Inspect, test, and release raw materials ∙ Proficiency with aseptic technique and compendial in vitro methods (e.g. sterility, mycoplasma, extraneous viral agents, residual formaldehyde) ∙ Prepare and qualify master cell stocks, master seed bacteria, master seed viruses per 9CFR requirements ∙ Perform hemagglutination, hemagglutination inhibition, and serum neutralization assays ∙ Conduct testing for endotoxin using the chromogenic and gel clot methods ∙ Run quantitative and relative potency ELISAs ∙ Perform virus, bacterial, and bacteriophage titrations ∙ Develop flow cytometry-based viability and identity test methods ∙ Assist with assay development, validation, and transfer to the QC laboratory ∙ Supervise and train laboratory staff ∙ Ensure compliance with regulatory filings, validation/stability protocols, and company standards ∙ Conduct investigations into deviations and OOS results • Participate as a member of the method validation, biosafety, bioresponse, and institutional biosafety committees (Biosafety Committee chair 2017-present; IBC co-chair 2018-present) Show less



Cytomatrix

• Woburn, MA

• Research Associate

  • 2001 - 2001

  ∙ Maintain tissue cultures, keep detailed testing records ∙ Assist in the development of cell-based screening assays for T cells and dendritic cells ∙ Analyze samples by flow cytometry and present results to peers ∙ Maintain tissue cultures, keep detailed testing records ∙ Assist in the development of cell-based screening assays for T cells and dendritic cells ∙ Analyze samples by flow cytometry and present results to peers