Process Development and Manufacturing Specialist

at University of Wisconsin, Waisman Biomanufacturing (view profile)
Location Madison, Wisconsin
Date Posted November 10, 2020
Category Biomanufacturing
Job Type Full-time
Address 1500 Highland Avenue

Description

The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of 14 centers of its kind in the United States, the Waisman Center encompasses laboratories for biomedical and behavioral research, a brain imaging center, and a clinical bio-manufacturing facility for the production of pharmaceuticals for early stage human clinical trials. In addition to its research efforts, the Center provides an array of services to people with developmental disabilities, offers numerous educational and outreach programs to young children and their families, and trains scientists and clinicians who will serve our nation in the future.

This position will work within the Waisman Biomanufacturing (WB) work unit. WB is a clinical manufacturing facility that produces biologics (gene therapeutics, cell therapeutics, recombinant proteins and vaccines) for Phase I and II Human Clinical Trials in compliance with current Good Manufacturing Practice (cGMP) guidelines.

The Process Development and Manufacturing Specialist will be responsible for developing and supporting manufacturing operations with any number of downstream and upstream processes, manufacturing processes, developing and executing Standard Operating Procedures (SOPs) for manufacturing operations, conducting equipment and process validation of manufacturing processes, performing manufacturing activities under cGMPs and complete project assignments as required to support all of these.