BIOPHARMACEUTICAL MANUFACTURING SUBJECT MATTER EXPERT
BIOPHARMACEUTICAL MANUFACTURING SUBJECT MATTER EXPERT
Job no: 225794-AS
Work type: Staff-Full Time
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.
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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.
Full Time: 100%Appointment Type, Duration:
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:
RESEARCHER(E05DN) or ASSOC RESEARCHER(E05FN) or ASST RESEARCHER(E05LN)Employment Class:
Academic Staff-RenewableJob Number:
225794-ASThe 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