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University of Wisconsin–Madison

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University of Wisconsin–Madison

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CELL MANUFACTURING SPECIALIST

Apply now(opens in a new window) Job no: 261300-AS
Work type: Onsite, Staff-Full Time
Department:SMPH/CARBONE CANC CTR/CANC CTR
Location: Madison
Categories: Client-Based Research Services

Job Summary:

The UW Carbone Cancer Center in partnership with UW Health launched the UW Program for
Advanced Cell Therapy (UW PACT) under the leadership of Jacques Galipeau, MD, Marilyn and Don Anderson Professor of Cancer Research and Assistant Dean for Therapeutics Discovery and Development. The mission of PACT is to provide UW Health and UWCCC patients access to novel personalized cellular therapies for cancer and immune disorders. This innovative, patient-centered program focuses on development and deployment of experimental cell therapies within the UW Health Hospital Cleanroom and Quality Control Laboratory. Ross O. Meyers, PhD serves as the Director of Advanced Cell Manufacturing, leading operations of clinical-grade cell therapy product manufacture and testing.

The successful candidate will manufacture, characterize and test novel cellular therapy products for FDA-approved investigational new drug (IND) applications under Current Good Manufacturing Practices (CGMP). These cell therapies include, but are not limited to antiviral T cells, Mesenchymal Stromal Cells, and anti-tumor T cells.

The person will report to the Director of Cell Manufacturing and will work in the CGMP cleanroom facility at the UW Health Hospital. The individual is responsible for the daily operation of the facility to ensure that it is compliant with applicable regulations and will perform necessary functions within the quality control laboratory.

The employee in this position will implement FDA regulations pertaining to cellular therapy and use tools and principles of CGMP to perform complex, multi-step procedures individually and in a team.

SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.

Responsibilities: Develops and supports process development and manufacturing operations. Functions as a team or project lead to facilitate smooth and timely execution of biomedical projects of low complexity.
  • 20% Performs process development and current Good Manufacturing Practice (cGMP) manufacturing of biopharmaceuticals for use in various clinical trials
  • 20% Develops and executes Standard Operating Procedures (SOPs) and Manufacturing Formulas (MFs) to support manufacturing activities
  • 10% Completes manufacturing documentation, prepares reports, and presents findings to internal and external audiences
  • 20% Prepares and validates equipment and stages materials for manufacturing operations
  • 10% Plans and executes client projects. Provides updates on project components and timelines to stakeholders as needed
  • 10% Co-develops manufacturing processes to produce scalable, repeatable methods to achieve required levels of quality and purity
  • 10% Maintains GMP-compliant cleanroom facility
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
B.S./B.A. in a Biotechnology applicable area of study, for example: Biochemistry, Biology, Cell and Molecular Biology, Medical Technology, Microbiology, Nutritional Sciences, Pharmaceutical Science, Pharmacology/Toxicology

Qualifications:

- 5 years of experience in cell culture, cell manufacturing/processing, cell-based bioassay,
clinical laboratory science, laboratory maintenance and supply management.
- Qualification/validation of equipment, instrumentation, processes
- Experience in the preparation of Standard Operating Procedures, Policies and
Qualification/Validation protocols.
- Knowledge of lab safety and use of standard lab equipment is required.
- Excellent technical documentation and communication skills.
- Exceptional attention to details.
- Commitment to quality improvements.
- Problem-solving and trouble-shooting skills.
- Ability to gown aseptically and work in a cleanroom environment for an extended period of
time.
- Good time management and organizational skills with ability to multi-task and adapt to changes in workflow, in an occasional high pressure and time-sensitive, team-oriented environment.
- Proficiency in Microsoft Office.

COVID-19 Considerations:

UW-Madison continues to follow necessary health and safety protocols to protect our campus from COVID-19. All employees remain subject to the COVID-19 Workplace Safety Policy: https://policy.wisc.edu/library/UW-5086. Please visit https://covidresponse.wisc.edu for the most up-to-date information.

Work Type:

Full Time: 100%

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

Appointment Type, Duration:

Ongoing/Renewable

Salary:

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

Additional Information:

- Work experience should demonstrate dependability, flexibility, and maturity. Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability. Employees will also be expected to uphold UWCCC core values as defined below:
- Diversity & Inclusiveness: Embrace differences and promote fairness and equity while fostering a sense of belonging.
- Respect: Demonstrate respect for self and others -- behave professionally.
- Integrity: Act with integrity and honesty.
- Teamwork: Commit to and demonstrate teamwork.
- Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance.

The School of Medicine and Public Health will not sponsor work visas for this position, thus, in compliance with federal law, all persons hired will be required to verify eligibility to work in the United States by completing the required I-9 form upon hire.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a resume and cover letter as a part of the application process. Please ensure that the resume and cover letter address how you meet the minimum/preferred qualifications for the position. You will also be asked to provide three professional/supervisor references during the application process. References will not be contacted prior to notifying you.

Contact:

Devonne Tucker
dtucker@wisc.edu
608-263-9404
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:

Process Dev & Mfg Scientist I(RE005)

Department(s):

A533400-MEDICAL SCHOOL/CARBONE CANC CTR/CANC CTR

Employment Class:

Academic Staff-Renewable

Job Number:

261300-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/

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: Central Daylight Time
Applications Close: Central Daylight Time

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