Quality Control Scientist

Waisman Biomanufacturing (WB) Quality Control (QC) Scientists perform analytical testing to support the development and manufacture of biological therapeutics for Phase I and Phase II clinical trials. WB specializes in the manufacture of protein, DNA, and cell-based therapeutics. The Quality Control team supports this effort through analytical testing of products, method development, and method qualification during manufacturing process development and clinical manufacturing.
QC Scientists are required to apply their technical knowledge in laboratory testing for product quality attributes and fulfill Current Good Manufacturing Practice (CGMP) requirements including but not limited to standard operating procedural compliance and detailed documentation standards.
As a QC Scientist, every day will be a different adventure based on a wide variety of client projects. QC Scientists spend the majority of their time performing analytical testing and supporting method development using a variety of analytical technologies. In this role, the QC Scientist will be performing testing including but not limited to Western Blot and SDS-PAGE protein analysis, HPLC purity analysis, and ELISAs. In addition to lab testing, this position executes lab equipment maintenance, supports documentation review, writes or revises standard operating procedures under cGMP guidelines, and completes project assignments as required to support manufacturing activities.
Waisman Biomanufacturing (WB) operates as a non-profit organization within the Waisman Center, at the University of Wisconsin - Madison, following a business model that includes multiple cross-functional teams (business, manufacturing, operations/facilities, quality assurance and quality control) to support contract-based clients. WB specifically focuses on the production of drug therapies for early stage human clinical trials.
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, several scientific research cores, and a clinical biomanufacturing 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.

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

Preferred
Associate's Degree in Biotechnology plus 3 years of experience
Preferred
Bachelor's Degree in Biochemistry, Biology, Chemistry or a related field is highly preferred.

Well-qualified applicants will have the following preferred experience:
- One to three years of experience working in a laboratory setting under current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (GLP).
- Technical experience performing or using analytical methods including UV/Vis spectroscopy, SDS-PAGE and Western Blot, residual DNA and host cell protein assays, and PCR.
- Experience with laboratory equipment operation including pH meters, balances, and multi-mode plate readers and/or the flexibility and desire to learn operation of new equipment. Experience operating and maintaining HPLC systems is not required but highly preferred.
- Demonstrated success in coordinating projects including collaboration, reporting team activities with good communication, and problem-solving skills.
- Self-motivated with an enthusiastic, positive attitude, and excellent multi-tasking skills.
- The ability to work both independently and in a fast-paced, client-oriented, team environment.
- Willingness to receive constructive feedback on documentation and procedural compliance as part of regulatory compliance and industry practices.

Full Time: 100%
It is anticipated this position requires work be performed in-person, onsite, at a designated campus work location.

Ongoing/Renewable

Minimum $49,000 ANNUAL (12 months)
Depending on Qualifications
Salary is negotiable and will be based on experience and skills. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits.

Applicants for this position will be considered for the titles listed in this posting. The title is determined by the experience and qualifications of the finalist.
A Criminal Background Check will be performed.
Must complete HIPAA and receive certification within the first 5 days of employment and annually thereafter.
Reporting requirements must be completed in a timely manner, including but not limited to effort reporting and outside activities reporting.

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 three references including contact information.

Melissa Henning
[email protected]
608-890-1388
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Quality Control Scientist I(RE009) or Quality Control Scientist II(RE010)

A34-OVCR/WAISMAN/WAISMAN

Academic Staff-Renewable

291046-AS