Job Summary:

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, clinics, a preschool, 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.

This position will have oversight responsibility and provide strategic direction for the Waisman Biomanufacturing facility. The incumbent is expected to provide strong scientific/technical leadership toward the development of research, manufacturing and training programs; will be responsible for identifying staffing requirements and recruitment; will supervise WB manufacturing, quality assurance/quality control, pre-clinical research , and administrative personnel; will identify facility equipment needs, coordinate procurement of equipment, guide validation of equipment, and support new technological developments; will manage and update the validation master plan as necessary; will pursue funding opportunities; will have responsibility for internal and external relations; and will have budget responsibility for the WB work unit.

Responsibilities:

Provides executive oversight and strategic planning for a center or program that has institutional recognition and scope and may direct the research activities undertaken by multiple aligned programs. Allocates resources, secures funding, and supervises staff to ensure program strategies and activities align with the institutional mission.

• 20% Develops, directs, and evaluates research program strategic planning initiatives and establishes objectives to ensure appropriate use of financial, administrative, and staffing resources in alignment with the strategic plan
• 20% Develops, implements, directs, and evaluates research program operating policies and procedures to comply with regulations, institutional policies, and unit objectives
• 20% Serves as the unit liaison and key spokesperson to internal and external stakeholder groups providing organizational information and representing the interests of the research program
• 10% Develops and audits research program budget(s)
• 10% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
• 20% Serve on WB project teams as a subject matter expert in science quality and regulatory affairs related to supplying biopharmaceuticals for early phase clinical trials.

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:

Required
Bachelor's Degree
A Bachelor's Degree is required. A degree in Microbiology, Cell Biology, Biochemistry, Molecular Biology, Virology, Biochemical Engineering or related field preferred.

Preferred
Master's Degree
A Master's Degree in the aforementioned fields preferred.

Preferred
Terminal Degree
A PhD in the aforementioned fields preferred.

Qualifications:

A minimum of four (PhD), seven (MS) or ten (BS) years of experience in clinical biomedical manufacturing and development (preferably gene therapy, cell therapy, viral and non-viral vector research or microbial sciences) is required.

A minimum of two years of relevant management experience required, including budgetary responsibility, client relations, and strong people and project management experience.

Hands-on experience in a laboratory production environment that operates in compliance with current Good Manufacturing Practices (cGMPs), or related environment, with strong biologics manufacturing, assay, and process development experience preferred.

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 $129,000 ANNUAL (12 months)
Depending on Qualifications

Additional Information:

A Criminal Background Check will be performed.

Must complete HIPAA 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.

How to Apply:

Contact:

Melissa Henning
melissa.henning@wisc.edu
608-890-1388
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Res Prog Dir (Inst)(RE117)

Department(s):

A348700-VCRGE/WAISMAN/WAISMAN

Employment Class:

Limited

Job Number:

269090-LI

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.