Quality Control Manager

at University of Wisconsin, Waisman Biomanufacturing (view profile)
Location Madison, Wisconsin
Date Posted June 6, 2019
Category Biomanufacturing
Job Type Full-time
Address 1500 Highland Ave

Description

WB's Quality Control (QC) Manager is responsible for the oversight and management of the QC group. Specifically, the QC Manager is responsible for oversight of QC project teams, managing current and upcoming client projects, coordinating, managing and supporting outsourced QC testing and providing technical expertise in drug development projects. A Master's or PhD in Biochemistry, Chemistry, Molecular Biology, Virology, Bacteriology or a related field. (Persons with a Bachelor's Degree in the aforementioned fields and a minimum of 10 years of relevant work experience may be considered.)

Qualified candidates will have the following required experience:
- A minimum of seven years of experience in the biotechnology industry. Previous experience in a cGMP facility in the field of manufacturing and development of biopharmaceuticals, cell therapies, or quality control.
-Technical expertise and hands-on experience in performing, developing and validating one of the following analytical method groups:
A. Protein Methods: HPLC, ELISA-based potency methods, molecular interaction technologies, SDS-PAGE, western blot and related densitometry analysis OR
B. Nucleic Acid Methods: PCR, qPCR, agarose gel electrophoresis and transfection methods OR
C. Cell-based Methods: flow cytometry-based stem cell characterization analysis technologies, cell counter and cell culture-based bioassays.
- At least two years of relevant management experience. Specifically, scheduling and monitoring projects, setting and adjusting priorities and training and supervising staff.

Well-qualified candidates will also have the following preferred experience:
- Experience creating and maintaining quality control documentation and data for product specifications, assay protocols, equipment calibration/maintenance and environmental monitoring.
- Experience preparing and executing Standard Operating Procedures (SOPs) to support biopharmaceutical and cell therapy product stability is highly preferred.
- Research and project leadership experience.
- Knowledge of QC testing requirements for U.S. and foreign regulatory agencies relevant to biopharmaceutical
and cell therapy products is highly preferred.
- Experience and/or knowledge of national and international shipment of manufactured biologics
is highly preferred.
- Excellent interpersonal and communication skills as well as experience working in cross functional teams
is highly preferred.
- Experience and desire to work in a highly collaborative, team-focused environment.

To find out more and to apply, please visit: https://jobs.hr.wisc.edu/en-us/job/501610/quality-control-manager

 

Unless confidentiality is requested in writing, information regarding applicants must be released upon request.  Finalists cannot be guaranteed confidentiality.  UW-Madison is an equal opportunity/affirmative action employer.

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