Director, Waisman Biomanufacturing Operations
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 serve as the Director of WB Operations. The Director of Operations will research and develop manufacturing processes, develop Standard Operating Procedures (SOPs) for manufacturing operations, oversee validation of manufacturing equipment and processes, train WB manufacturing personnel, and oversee scheduling and execution of operations activities. Additionally, this position is responsible for oversight of production facilities, including cleaning, maintenance, and validation.
RESPONSIBILITIES
Assists with the oversight and strategic planning for a center or program that has institutional recognition and scope and may assist with directing a variety of research activities. Allocates resources, secures funding, and supervises staff to ensure program strategies and activities align with the institutional mission.
- 10% Determines unit personnel needs and the unit personnel resource allocation plan
- 10% Serves as a unit liaison to internal stakeholder groups to foster cross-unit partnership efforts regarding research programs and activities
- 10% Serves as a consultant to project directors and provides technical expertise to research and operational personnel
- 10% Collaborates with project directors and the full range of clients whose knowledge and expertise varies
- 20% Manages large research projects for the institution
- 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
- 10% Assists with planning, implementation, and management of strategic initiatives for a center or program that has institutional recognition
- 5% Provide subject matter expertise and lead efforts to procure, build, validate, maintain and calibrate facilities equipment and infrastructure to support manufacturing of biopharmaceuticals
- 5% Develop and maintain alarm management protocols and support after-hours emergency response
- 5% In collaboration with WB Director and Director of Quality Assurance, oversee and ensure operations department compliance with current Good Manufacturing Practices (cGMPs)
- 5% Provide project teams and staff with subject matter expertise and training regarding manufacturing science and engineering for biopharmaceuticals
EDUCATION
Required
Bachelor's Degree in Biochemistry, Chemistry, Molecular Biology, Virology, Bacteriology, Biochemical Engineering or a related field
Preferred
Master's Degree in the aforementioned fields
Preferred
PhD in the aforementioned fields
QUALIFICATIONS
Qualified candidates will have the following required experience:
- A minimum of four (PhD), seven (MS) or ten (BS) years of experience in manufacturing and/or manufacturing process development.
- At least two years of relevant management experience. Specifically, scheduling and monitoring projects, setting and adjusting priorities and training and supervising staff.
- Expertise in development, validation, execution and monitoring of manufacturing operations.
- Expertise in cGMPs and application to the manufacture of pharmaceuticals, biologics or medical devices.
- Expertise in one or more of the following areas required: fermentation, cell culture, virus production, liquid chromatography, filtration, aseptic fill operations, cell manipulation/expansion. Expertise in multiple areas is preferred.
- Expertise in specification, implementation, and validation of manufacturing equipment and facilities infrastructure.
Well-qualified candidates will also have the following preferred experience:
- Experience or training in monitoring and alarm management systems, especially Metasys and Rees.
- Experience with design or oversight of facilities construction and upgrade projects.
- Excellent interpersonal and communication skills as well as experience working in cross functional teams.
- Experience and desire to work in a highly collaborative, team-focused environment.
- Relevant experience pertaining to the above qualifications in a biopharmaceutical environment.
The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, 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 through diversity and encourage all qualified individuals to apply.