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University of Wisconsin - Madison

Location: MadisonWI 53705 Document ID: AD136-0EGM Posted on: 2019-05-0605/06/2019 Job Type: Regular

Job Schedule:Full-time
2019-06-05
 

RESEARCHER - QUALITY CONTROL SUBJECT MATTER EXPERT


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 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) team works with Manufacturing and Quality Assurance teams to test biopharmaceutical products and document results for in-process and release testing.

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.

Position Duties:
List of Duties

Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Degree and Area of Specialization:
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.

Minimum Years and Type of Relevant Work Experience:
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.

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.

Additional Information:
- A Criminal Background Check will be performed.
- Must complete HIPAA and receive certification within the first 5 days of employment and annually
thereafter within 5 days of notification.
- Must complete Preventing Sexual Harassment and Sexual Violence at UW-Madison training.
- Reporting requirements must be completed in a timely manner, including but not limited to effort reporting
and outside activities reporting.

Department(s):
A348700-VCRGE/WAISMAN/WAISMAN

Work Type:
Full Time: 100%

Appointment Type, Duration:
Ongoing/Renewable

Salary:
Minimum $50,000 ANNUAL (12 months)
Depending on Qualifications

Instructions to Applicants:
Please click on the "Apply Now" button to begin the application process. You will be asked to upload a resume, cover letter and a list of 3 references including contact information.

Contact:
Melissa Strupp
melissa.henning@wisc.edu
608-890-1388
Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )

Official Title:
RESEARCHER(E05DN) or ASSOC RESEARCHER(E05FN) or ASST RESEARCHER(E05LN)

Employment Class:
Academic Staff-Renewable

Job Number:
96952-AS


The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.

If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://oed.wisc.edu/disability-accommodation-information-for-applicants/

Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.

Applications Open: Apr 5 2019 Central Daylight Time
Applications Close: May 6 2019 11:55 PM Central Daylight Time


To apply please click here!