Managing Director, Waisman Biomanufacturing
$150,108–$150,108 year
On-siteMadison, Wisconsin, United States
Job Summary
Oversee the Waisman Biomanufacturing facility, providing strategic direction for clinical manufacturing of biologics for Phase I and II human clinical trials in compliance with cGMP guidelines. Supervise manufacturing, quality assurance, pre-clinical research, and administrative personnel while managing the validation master plan and identifying facility equipment needs. Lead project teams as a subject matter expert in science quality and regulatory affairs, develop research program budgets, and pursue funding opportunities. Exercise supervisory authority over at least 2.0 full-time equivalent employees, including hiring, performance management, and disciplinary actions. Serve as the unit liaison to internal and external stakeholders, representing the interests of the research program and managing internal and external relations.
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
- A Master's Degree or PhD in Microbiology, Cell Biology, Biochemistry, Molecular Biology, Virology, Biochemical Engineering, or a related field
Desired 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
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