Managing Director, Waisman Biomanufacturing

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.

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.

The Managing Director 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.

• 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

• Develops and audits research program budget(s)

• 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

• 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

• Develops, implements, directs, and evaluates research program operating policies and procedures to comply with regulations, institutional policies and unit objectives

• 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

Department:

Waisman Center

Compensation:

$150,108 minimum; Salary is negotiable and will be based on education, 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 and retirement benefits.

Required Qualifications:

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

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

Preferred Qualifications:

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.

Education:

A Master's Degree or PhD in Microbiology, Cell Biology, Biochemistry, Molecular Biology, Virology, Biochemical Engineering, or a related field is required.

Additional Information:

• A Criminal Background Check will be performed.

• The successful applicant will be required to complete HIPAA training and receive certification upon hire and annually thereafter.

How to Apply:

Please click the Apply Now box to start the application process. Please upload the following documents:

• A current resume or CV highlighting your experience, training, and/or credentials relevant to the position.

• A cover letter describing your interest in the position, summarizing your relevant experience, and explaining how your background aligns with the requirements of the role.

Please note, there will only be one attachment field. You must upload all of your documents in the attachment field. Applications submitted without both documents may still be considered, but both a cover letter and resume are required to guarantee consideration.

Professional references will be requested of all final candidates.

Contact Information:

For questions regarding this position or posting, please contact Melissa Henning, Human Resources Manager, at (608)890-1388 or melissa.henning@wisc.edu.

Relay Access (WTRS): 7-1-1. SeeRELAY_SERVICEfor further information.

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.

The University of Wisconsin-Madison is an Equal OpportunityEmployer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgroundsand encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website.

To request a disability or pregnancy-related accommodationfor any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR)in the division you are applying to.Please make your request as soon as possible to help the university respond most effectively to you.

Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including 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.