Director of Biomanufacturing

Position Summary

Director of Biomanufacturing – Provide site‑level leadership for manufacturing operations at Catalent’s Madison biologics facility. Ensure safe, compliant, and on‑time execution of clinical and commercial manufacturing programs across a wide range of biologics, from early development to commercial production.

Madison, WI – 100% Onsite

Lead the manufacturing organization, partner with cross‑functional teams, and drive performance through data‑driven metrics and continuous improvement.

• Own manufacturing execution across assigned programs, ensuring safety, quality performance, schedule adherence, cost control, and client commitments.
• Lead a multi‑layer manufacturing organization, managing performance, capability development, engagement, and succession planning.
• Act as the Manufacturing lead in high‑level client interactions, including strategy, readiness, risk assessments, issue resolution, and performance communication.
• Partner with MST, Quality, PD, Engineering & Facilities, and Project Management to integrate manufacturing requirements into program strategy, validation planning, and regulatory readiness.
• Ensure manufacturing execution aligns with cGMP expectations through standard work, investigation engagement, CAPA effectiveness, and continuous inspection readiness.
• Champion a Manage Through Metrics culture, using KPIs to drive right‑first‑time execution, deviation reduction, and continuous improvement.
• Lead and sponsor continuous improvement initiatives to improve efficiency, reduce waste, strengthen compliance, and impact financial performance.
• Provide manufacturing leadership during audits and inspections, supporting timely responses and sustained improvements in site readiness.
• Model Catalent values, professional client engagement, and a strong operational mindset across the manufacturing organization.

• Doctor of Philosophy in a Scientific, Engineering, or Biomanufacturing discipline with 8 years of relevant experience; or Master’s degree with 12 years of relevant experience; or Bachelor’s degree with a minimum of 15 years of relevant experience.
• 6 years of people‑leadership experience in manufacturing or operations.
• 10 years of experience in biologics manufacturing with strong understanding of upstream and downstream processing.
• Proven track record of delivering results as a biologics manufacturing leader with deep clinical and commercial CDMO expertise.
• Strong knowledge of validation (process, equipment, facility) and cGMP compliance in regulated manufacturing environments.
• Demonstrated ability to lead, develop, and scale high‑performing teams in fast‑paced, growth‑oriented settings.
• Client‑focused leadership experience managing expectations, resolving execution issues, and communicating risk and readiness.
• Skilled at navigating complex discussions and driving alignment across internal teams and external stakeholders.
• Strategic, data‑driven operator with strong business acumen and ability to execute cross‑functional initiatives in matrixed organizations.
• Demonstrable leadership experience at Catalent (including participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

• Demonstrated experience supporting scale‑up activities (e.g., 250L to 4,000L).

• Defined career path and annual performance review and feedback process.
• Dynamic, fast‑paced work environment.
• Generous 401(k) match and paid time off accrual.
• Medical, dental, and vision benefits effective day one of employment.
• Opportunities to advance career within a growing international company.

Catalent is an Equal Opportunity Employer, including disability and veterans.