Greater Madison Area
Experienced biologist with a strong background in chemistry obtained in both academic and corporate settings. Proficient with testing in GLP and GMP requirements as well as creating and validating methods within those environments. Familiar working with several aspects of a biotechnology business, such as quality control, intellectual property, financials, and leadership.
I was responsible for project management of the new product line portfolio research and development projects as they moved from feasibility to launch. I also made several optimizations and standardizations to the overall lifecycle process, including post-launch, while there. I managed several internal projects around integrating new software including: working artificial intelligence into everyday processes, transferring several business units’ processes from the Microsoft Office Suite to Smartsheet while also creating a new portfolio management system within the software to streamline the R&D process, and implementing an electronic notebook system within the production environment to reduce the need for paper.
My role was as a Technical Project Manager. Work with internal and external stakeholders, to create and maintain technical and regulatory aspects of projects meet necessary standards and match contractual requirements for phase III through commercial inhalation and small molecule pharmaceutical products at a revenue level of approximately $200k/month Responsible for coordinating and planning validation, transfer activities, GMP, and other requested support testing for several inhalation and small molecule products in API, DP, DS, and raw material states Helped lead multiple projects through global regulatory approval processes
I was responsible for manufacturing of several types of MRI phantoms as well as assisting with any and all parts of the start-up business. That included marketing, setting up a lab, researching supplies, investigating business hurdles, and administrative responsibilities.
-A key technical expert in carbohydrate chemistry. Regularly operate Gas Chromatography, High Performance Liquid Chromatography, and Ion Chromatography systems. -Instrumental in the set-up of a new lab in Harrogate, England. Performed a variety of tasks, including instrumentation set-up, method transfers, quality controls and processes, and training of personnel -Leading a project to transition four methods through a validation process to meet stricter quality requirements leading to more robust testing. -Leading an effort to develop a new method to test sugar alcohols in a more efficient and higher quality manner.
-Converted over a dozen fMRI scans of human brains to provide data for a university study
-Created data that bolstered experiments on glial cells through cell culture, solution preparation, PCR, ELISA, and bacterial transfection