Quality Control Subject Matter Expert

at University of Wisconsin, Waisman Biomanufacturing (view profile)
Location Madison, WI
Date Posted April 8, 2019
Category Contract GMP Manufacturing
Job Type Full-time
Address 1500 Highland Ave


Waisman Biomanufacturing, at the University of Wisconsin-Madison 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 Researcher will serve as a Subject Matter Expert (SME) and will provide technical expertise in the development and optimization of analytical methods for GMP-manufactured products. This includes designing and developing analytical method reports, Quality Control Procedures (QCPs), Standard Operating Procedures (SOPs), Quality Control Specifications (QCSs), Stability protocols and Validation protocols. Document review and verification of the work of other Quality Control staff will also be a primary work function. A Master's Degree or PhD in Bioanalytical Chemistry, Pharmacology/Toxicology, Pharmaceutical/Biopharmaceutical Sciences, Biochemistry, Chemistry, Molecular Biology, Immunology or a related field is highly preferred. Persons with a Bachelor's Degree in Biochemistry, Molecular Biology, Pharmacology/Toxicology or related field and a minimum of 10 years of relevant work experience will be considered.

Technical expertise in the development, understanding, performance, optimization and trouble-shooting in one of the following analytical method groups is highly preferred:

- Protein methods: High performance liquid chromatography (HPLC), ELISA-based potency methods, molecular interaction technologies, sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE),western blot and related densitometry analysis OR

- Nucleic acid methods: polymerase chain reaction (PCR), quantitative polymerase chain reaction (qPCR), agarose gel electrophoresis and transfection methods OR

- Cell-based methods: flow cytometry-based stem cell characterization analysis technologies, cell counter and cell culture-based bioassays.

- Experience in statistical data analysis of bioassays, including related software programs.

- Research and project leadership experience related to the production of biopharmaceuticals and/or cell therapies.

- Excellent interpersonal and communication skills as well as experience working in cross functional teams.

- Ability to work effectively both independently and in a fast-paced, client-oriented team environment.

A minimum of 2 years of graduate and/or post-graduate degree experience in the development and performance of methods of biomolecular analysis and/or cell-based bioassay is required.

Previous laboratory experience in biopharmaceutical analysis under current Good Manufacturing Practices (cGMP) and/or Good Laboratory Practices (GLP) is highly preferred.

To find out more and to apply, please visit: https://jobs.hr.wisc.edu/en-us/job/500950/

Unless confidentiality is requested in writing, information regarding applicants must be released upon request. Finalists cannot be guaranteed confidentiality. UW–Madison provides equal employment opportunity for all persons and is in compliance with State and Federal regulations.

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