Process Development

2 weeks ago

Madison, United States UW-Madison Full time

Job Summary:

As a Process Development and Manufacturing Scientist, every day will be a different adventure based on a wide variety of client projects. Because not every day is the same, you have the exciting opportunity to develop a broad skillset and become a subject matter expert (SME). PD and Manufacturing Scientists are responsible for developing and supporting manufacturing operations with any number of downstream and upstream manufacturing processes, developing and executing Standard Operating Procedures (SOPs) for manufacturing operations, conducting equipment and process qualifications, performing manufacturing activities under cGMP guidelines and completing project assignments as required to support all of these.

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.

Responsibilities:

Process Development and Manufacturing Scientist III (RE007)
Process Development and Manufacturing Scientist II (RE006)
Process Development and Manufacturing Scientist I (RE005)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

Education:

Preferred
Bachelor's Degree in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field.

Preferred
Associate's Degree in related field and one year of relevant experience will be considered in lieu of Bachelor's Degree.

Qualifications:

Well-qualified applicants will have the following preferred experience:
- 1+ years of experience working in one of the following is highly preferred: research laboratory, pilot plant, biomanufacturing and/or process development in biopharmaceuticals facility. Relevant undergraduate research experience may be considered.
- Prior experience in any of the following areas: Aseptic technique, adherent or suspension mammalian cell culture, stem cell culture and directed differentiation, clonal selection, controlled system single-use bioreactors, large scale cell concentration.
- Experience with laboratory equipment and analytical methods: Automated cell counters (Nexcelom 2000, Nucleocounter NC-200), flow cytometry, metabolite bioanalysis (Cedex Bio Analyzer), CliniMACs cell selection, Applicon ez-Controller, KSep cell concentration, gel electrophoresis, western blots, ELISAs, DNA/RNA isolation, column chromatography, TFF, PCR.
- Experience with equipment operation and/or interest in learning operation of new equipment.
- Experience with current Good Manufacturing Practices (cGMPs) and their application to the manufacture of biopharmaceuticals or interest in learning cGMP requirements.

Salary:

Minimum $50,000 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.

Additional Information:

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.

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.

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