Waisman Biomanufacturing

Waisman Biomanufacturing cGMP manufacturing services Waisman has extensive experience in cGMP production of biologics for phase I/II human clinical trials.

In addition, Waisman provides comprehensive Chemistry, Manufacturing, and Control (CMC) support for Investigational New Drug (IND) filings. Waisman Biomanufacturing has a proven track record for producing high-quality clinical trial material for both large and small biotech companies, universities, and federal agencies such as the National Institutes of Health (NIH). Since opening its cGMP facilit

y in 2001, Waisman Biomanufacturing has manufactured over 320 clinical grade products and has earned a reputation for working closely with clients for cost effective and timely manufacture of quality products. We strive to meet these high standards with each product campaign.

Waisman Biomanufacturing is currently searching for dedicated, knowledgeable candidates to fill one of our Process Devel...
06/01/2023

Waisman Biomanufacturing is currently searching for dedicated, knowledgeable candidates to fill one of our Process Development and Manufacturing Scientist positions. If this opportunity sounds interesting to you, apply to join our team! Applications are open now through June 14th:

Job 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...

03/24/2023

Waisman Biomanufacturing is currently hiring for the role of Director of Operations! Applications will be accepted now through April 9th. Come be a part of the exciting and innovative work we do!

07/06/2022

Waisman Biomanufacturing is excited to announce our new partnership with BriaCell to manufacture and supply prostate cancer immunotherapy! BriaCell is a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, and their Phase I/II trial in prostate cancer is expected to follow upon the completion of the project.

10/28/2021

Waisman Biomanufacturing is currently hiring for the role of Process Development and Manufacturing Scientist I. Applications will be accepted through Sunday, October 31st.

10/25/2021

Waisman Biomanufacturing is currently hiring for the role of Quality Control Scientist and will accept applications through Tuesday, November 2nd.

In June, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal bur...
07/27/2021

In June, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns. This is the first approved therapy in Waisman Biomanufacturing's book of achievements! Congratulations to everyone involved, past and present, who helped make StrataGraft successful.

FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements

07/27/2021

Waisman Biomanufacturing is currently hiring for the role of Quality Control Specialist. Applications will be accepted through Monday, August 9th.

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.

https://jobs.hr.wisc.edu/en-us/job/509851/quality-control-specialist

06/02/2021

Waisman Biomanufacturing is also hiring for the role of Manager of Operations. Applications will be accepted through Friday, June 25th.

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 Operations team is responsible for process development, manufacturing, and the specialized equipment and facilities associated with biologics manufacturing. Operations works with Quality Control, Quality Assurance, and Business teams to execute projects for WB's academic and industry clients.

This position will serve as WB's Manager of Operations. The Manager of Operations will research and develop manufacturing processes, develop Standard Operating Procedures (SOPs) for manufacturing operations, oversee validation of manufacturing equipment and processes, train WB manufacturing personnel, and oversee scheduling and ex*****on of operations activities. The Manager of Operations is responsible for oversight of production facilities, including cleaning, maintenance, and validation. After hours response to facilities and equipment alarms is required.

06/02/2021

Waisman Biomanufacturing is currently hiring for the role of Quality Control Specialist. Applications will be accepted through Tuesday, June 15th.

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 quality control specifications (QCSs), and reviewing/verifying the work of teammates.

03/12/2021

Waisman Biomanufacturing is currently hiring for the role of Quality Assurance Specialist.

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 Quality Assurance (QA) Specialist's primary responsibilities will include QA documentation and record keeping, QA raw material control, quality systems (documentation control, failure investigation, deviation reporting, etc.) and training documentation. They will also provide backup support for external audits.

12/22/2020

In Wisconsin, scientists have been in the thick of research into the coronavirus and ways to fight its spread and effects.

Waisman Biomanufacturing is currently hiring for a Quality Control Specialist. The Waisman Center is dedicated to the ad...
12/22/2020

Waisman Biomanufacturing is currently hiring for a Quality Control Specialist.

The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of only 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. 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, performance of environmental monitoring (EM), shipping and outsourcing functions, writing and updating standard operating procedures (SOPs), reporting quality control specifications (QCSs), and reviewing/verifying the work of teammates.

Find jobs at University of Wisconsin–Madison

Address

1500 Highland Avenue
Madison, WI
53705

Telephone

+16082629547

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