Ashley Schwarzenstein Email & Phone Number

Madison, Wi, Us

Fitchburg, Wisconsin, United States

Madison, Wisconsin, United States

• Performed complex cell and tissue culture to develop and refine StrataGraft and ExpressGraft skin substitute products• Worked independently to plan, execute, and analyze laboratory experiments to support product and pipeline research in regenerative medicine, advanced cellular therapies, and tissue engineering• Served as key technical liaison to facilitate technology transfer to partner institute as part of the effort to develop an automated, closed-system production process• Collaborated with the Quality Control department to meet several FDA post-marketing commitments. Generated new standard operating procedures as part of the development of new cell-based identity assays and supported the qualification and validation work• Acted as technical lead to develop custom plasticware for multiple projects. Performed critical studies assessing the performance of the new plasticware components• Trained and supervised junior research staff in performance of role-specific lab activities• Performed general lab management responsibilities including resource forecasting and equipment management

Madison, Wisconsin Area

• Acted as project lead to design and finalize tools and methods to support manufacture of skin substitutes in smaller formats. Facilitated communication with exterior vendor to make product improvements and acquire necessary supporting equipment. Performed testing to assess novel custom equipment• Developed and executed clinical-use studies evaluating the robustness of thaw procedures for StrataGraft construct to support biologics license application. Results informed failure modes and effects analysis and preparation procedures in product insert• Performed sample preparation for extractables and leachables study for clinical-use materials• Evaluated the suitability of various dressings, wound care solutions, and fibrin sealants for use with StrataGraft• Characterized tissue responses to varying temperature excursions during transfer and/or shipping. Supported analysis of current processes and proposed refinements. Performed heat transfer analyses, designed equipment, and executed studies to improve understanding and control of the process• Established partnerships with several companies in order to source a variety of custom products, including culture dishes and product packaging

Madison, Wisconsin Area

• Contributed to the development of homework and exams• Graded the quizzes and exams of fellow students in a timely manner• Held office hours to ensure students understand course concepts

Coralville, Ia

• Worked with basic laboratory equipment• Basic cell culture and maintenance• Designed and fabricated calcium alginate gel for use as cell culture substrate

Master'S Degree, Biomedical/Medical Engineering

Bachelor'S Degree, Mechanical Engineering

Activities and Societies: Honor Society of Phi Kappa Phi, National Honor Society of Leadership and SuccessMinor in Mathematics Graduated.