BIOPHARMACEUTICAL MANUFACTURING SUBJECT MATTER EXPERT
- Employer
- University of Wisconsin-Madison
- Location
- Madison
View more
- Institution Type
- Four-Year Institution
Job Details
Job no: 225794-AS
Work type: Staff-Full Time
Department:VCRGE/WAISMAN/WAISMAN
Location: Madison
Categories: Research, Scientific
The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of 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 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.
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 (QA) teams to test biopharmaceutical products and document results for in-process and final product release testing.
The Researcher will serve as a Subject Matter Expert (SME) and will provide technical expertise in the areas of cell therapies, large scale cell culture, and/or purification of biologics. This includes designing, developing and executing manufacturing processes to support the production of clinical trial materials for WB and its clients and new project-specific process development, assay development and manufacturing processes for the scale-up and manufacturing of biotherapeutics.
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
A Master's degree or PhD in Cellular Biology, Microbiology, Molecular Biology, Biochemical Engineering or a related field is highly preferred. Persons with a Bachelor's Degree in the aforementioned fields and a minimum of 5 years of biopharmaceutical industry work experience will be considered.
Minimum Years and Type of Relevant Work Experience:Well-qualified applicants will have the following preferred experience and knowledge:
- 2+ years of experience in process development and/or manufacturing of biotherapeutics for Phase I/II clinical trials. Previous work experience in the biotechnology industry is highly preferred.
- Expertise in one or more of the following areas: large scale microbial or mammalian cell culture, bioreactors, viral vector production, cell therapies (hESC, iPSC, MSC), chromatography, tangential and dead-end filtration, aseptic processing.
- Experience with assay development related to biopharmaceuticals, especially flow cytometry, qPCR, ELISA, HPLC.
- Expertise with automated equipment used in biologics manufacturing.
- Experience and desire to work in a highly collaborative, team-focused environment.
- Expertise in development, validation, execution, monitoring and manufacturing of novel biotherapeutics, vaccines, and related components as well as manufacturing operations as required.
- Expertise in cGMPs and application to the process development and manufacturing of biotherapeutics or vaccines.
- Research and project leadership experience related to the production of biopharmaceuticals.
A Criminal Background Check will be performed.
Must complete HIPAA training and receive certification within the first 5 days of employment and annually thereafter within 5 days of notification.
Reporting requirements must be completed in a timely manner, including but not limited to effort reporting and outside activities reporting.
A348700-VCRGE/WAISMAN/WAISMAN
Work Type:Full Time: 100%
Appointment Type, Duration:Ongoing/Renewable
Salary:Minimum $50,000 ANNUAL (12 months)
Depending on Qualifications
Please click on the "Apply Now" button to begin the application process. You will be asked to upload a resume, cover letter and list of references.
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. )
RESEARCHER(E05DN) or ASSOC RESEARCHER(E05FN) or ASST RESEARCHER(E05LN)
Employment Class:Academic Staff-Renewable
Job Number:225794-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://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/
The University of Wisconsin-Madison is engaged in a Title and Total Compensation (TTC) Project to redesign job titles and compensation structures. As a result of the TTC project, official job titles on current job postings may change in Fall 2020. Job duties and responsibilities will remain the same. For more information please visit: https://hr.wisc.edu/title-and-total-compensation-study/.
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: Sep 4 2020 Central Daylight Time
Applications Close:Sep 18 2020 11:55 PM Central Daylight Time
Organization
In achievement and prestige, the University of Wisconsin–Madison has long been recognized as one of America's great universities. A public, land-grant institution, UW–Madison offers a complete spectrum of liberal arts studies, professional programs and student activities, and many of its programs are hailed as world leaders in instruction, research and public service. Spanning 935 acres along the southern shore of Lake Mendota, the campus is located in the city of Madison.
The university trace
s its roots to a clause in the Wisconsin Constitution, which decreed that the state should have a prominent public university. In 1848, Nelson Dewey, Wisconsin’s first governor, signed the act that formally created the university, and its first class, with 17 students, met in a Madison school building on February 5, 1849.
From those humble beginnings, the university has grown into a large, diverse community, with about 40,000 students enrolled each year. These students represent every state in the nation, as well as countries from around the globe, making for a truly international population.
UW–Madison is the oldest and largest campus in the University of Wisconsin System, a statewide network of 13 comprehensive universities, 13 freshman-sophomore transfer colleges and an extension service. One of two doctorate-granting universities in the system, UW–Madison’s specific mission is to provide “a learning environment in which faculty, staff and students can discover, examine critically, preserve an
d transmit the knowledge, wisdom and values that will help insure the survival of this and future generations and improve the quality of life for all.”
The university achieves these ends through innovative programs of research, teaching and public service. Throughout its history, UW–Madison has sought to bring the power of learning into the daily lives of its students through innovations such as residential learning communities and service-learning opportunities. Students also participate freely in research, which has led to life-improving inventions ranging from more fuel-efficient engines to cutting-edge genetic therapies.
The Wisconsin Idea
Students, faculty and staff are motivated by a tradition known as the “Wisconsin Idea,” first started by UW President Charles Van Hise in 1904, when he declared that he would “never be content until the beneficent influence of the university [is] available to every home in the state.” The Wisconsin Idea permeates the university’s work and helps forge close working relationships among university faculty and students, and the state’s industries and government.
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