University of Wisconsin - Madison

Position Vacancy Listing

PVL # 237880

Position Summary:
The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of 15 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. WB's Quality Control (QC) Specialists work with Manufacturing and Quality Assurance teams to test biopharmaceutical products and document results for in-process and release testing. The QC Specialist will be responsible for running standard assays for product characterization and quality testing, shipping and outsourcing functions, writing and updating standard operating procedures (SOPs), reporting test results against specifications, and reviewing/verifying the work of teammates.

Principal duties:
Performance of Test Methods (50%):
Perform routine QC assays and release testing in accordance with approved cGMP procedures to support manufacturing and product stability testing. These methods include general microbiological testing, sterility, microbial limits, microbial identification, UV-vis spectrophotometry, endotoxin testing, PCR, HPLC, SDS-PAGE, western blot and identity testing. Record and analyze test results in accordance with approved Standard Operating Procedures (SOPs).

Environmental Monitoring (20%):
- Facility-based Environmental Monitoring Support: Coordinate the environmental monitoring room schedules with Waisman Biomanufacturing manufacturing and cleaning teams. Perform GMP environmental monitoring (viable, non-viable) for the cleanroom facility. Submit microbial isolates for identification. Assist with data reporting, trending and tracking of viable and non-viable monitoring results. Facilitate environmental monitoring documentation and archiving. Assist with managing environmental monitoring (EM) student hourly staff. This includes hiring, scheduling, training certification and documentation review.
- Client-based Environmental Monitoring Support: Provide a variety of environmental and personnel monitoring for aseptic processing projects such as aseptic filling and cell therapeutic production in cooperation with manufacturing teams. Set-up, organize and order required supplies. This type of monitoring requires static monitoring prior to product fill, dynamic continuous monitoring during the fill and static monitoring after the fill is complete.

Shipping and Outsourced QC Testing (20%):
- Prepare final product materials for shipment. This includes identifying appropriate transport services and import/ documentation needs and monitoring shipping temperature during transit.
- Prepare sample submission forms and package samples for shipment to Contract Research Organization (CRO) Facilities for testing and long-term storage facilities in accordance with SOPs.

Equipment Procurement, Calibration, Maintenance and Validation (10%):
- Perform and document scheduled laboratory equipment maintenance and calibration according to SOPs. Coordinate and perform routine laboratory and equipment cleaning and maintenance.
- Evaluate and purchase QC lab supplies and equipment as needed.
- Assist with the development and revision of SOPs for current and new laboratory instrumentation.

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