Director, Waisman Biomanufacturing Operations

This position will serve as the Waisman Biomanufacturing (WB) Director of 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.

Waisman Biomanufacturing (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. 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 control and quality assurance) to support contract-based clients.

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.

• Provide subject matter expertise and lead efforts to procure, build, validate, maintain and calibrate facilities equipment and infrastructure to support manufacturing of biopharmaceuticals

• Serves as a consultant to project directors and provides technical expertise to research and operational personnel

• In collaboration with WB Director and Director of Quality Assurance, oversee and ensure operations department compliance with current Good Manufacturing Practices (cGMPs)

• Develop and maintain alarm management protocols and support after-hours emergency response

• Provide project teams and staff with subject matter expertise and training regarding manufacturing science and engineering for biopharmaceuticals

• Collaborates with project directors and the full range of clients whose knowledge and expertise varies

• Manages large research projects for the institution

• 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

• Determines unit personnel needs and the unit personnel resource allocation plan

• Assists with planning, implementation, and management of strategic initiatives for a center or program that has institutional recognition

• Serves as a unit liaison to internal stakeholder groups to foster cross-unit partnership efforts regarding research programs and activities

Waisman Center

$96,000 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.

• 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.

• 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.

A Bachelor's Degree in Biochemistry, Chemistry, Molecular Biology, Virology, Bacteriology, Biochemical Engineering or a related field is required; A Master's Degree or PhD in the aforementioned fields is preferred.

Additional Information:

• After hours and weekend response to facilities and equipment alarms is required.

• Criminal Background Check will be performed.

• The successful applicant will be required to complete HIPAA training 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.

Please click the "apply now" button to begin the application process. You will be aked to upload a resume, cover letter, and a list of three references.

Melissa Henning

Email: melissa.henning@wisc.edu

Phone: (608)890-1388

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