Penny Sattgast is an expert in leading and managing clinical trials and developing and designing scientific and clinical protocols in virology and bacteriology. She has vast array of experience with both internal clinical trials and running trials through third-party Clinical Research Organizations (CROs), designing studies for non-GxP and GCP, conducting data analyses and writing final technical reports for USDA regulatory submission. She has more than 25 years of experience in numerous leadership and management positions with 15 of those years in the life sciences industry. Penny is the currently the President of PCS Biotech Services and is a USDA and biotechnology collaborator for the Scullion Strategy Group.
She is also seasoned in data analytics, data management, data QC, laboratory efficiencies in virology, bacteriology, cell culture, assay development and bioreactor processes development (upstream),vaccine formulation, vaccine manufacturing and R&D project budgeting. She has extensive experience in developing bacterial and viral challenge models for both swine and bovine, has clinical field experience in both large and small lab animal and in working with the USDA and other global regulatory agencies. She is also familiar with monoclonal antibodies (mAbs) and even conducted her Master’s Research work on in vitro characterization of monoclonal and polyclonal antibodies and evaluation of their protective role in the host and in vivo for use in a swine bacterial vaccine potency test.
In the animal health industry, she has worked for companies such as Elanco Animal Health, A Division of Eli Lilly and Company, Novartis Animal Health and Grand Laboratories in various study operations, clinical project management and process and research scientist roles. She was also the US Diversity and Inclusion (D&I) Council Officer and the Larchwood, Iowa, D&I Site Leader during her time at Novartis Animal Health.
In addition to Penny’s scientific experience, she has also held roles as a Sales Designer for Starmark Cabinetry in Sioux Falls, South Dakota, where she was responsible for growing new and remodeling construction sales within her territory and was President of the Board of Education in the Harrisburg, South Dakota, District. In that role, she led all School Board Meetings, managed school district budgets, successfully campaigned and passed bond issues for new schools and was the public face and media representative for the Harrisburg School District.
Penny Stattgast holds a Master of Science Degree in Biology from South Dakota State University in Bookings, South Dakota and a Bachelor of Science in Biology for Information Systems from Dakota State University in Madison, South Dakota.
For more information, visit https://www.linkedin.com/in/penny-sattgast-ms-6a509483/