Director of Biomanufacturing

Director of Biomanufacturing

Position Summary:

Catalent's Madison facility is a state-of-the-art biologics development and manufacturing site focused on delivering advanced solutions for biopharmaceutical products. The site features modern laboratories and flexible manufacturing spaces designed to support a wide range of biologics programs, from early development through commercial production. With cutting-edge technology and a collaborative environment, the Madison location plays a key role in driving innovation and quality in the life sciences industry.

This dynamic setting offers employees the opportunity to work on impactful projects that help bring life-changing therapies to patients worldwide.

We have an opportunity for the Director of Biomanufacturing - Execution to join our team.

This role offers the chance to be part of an entrepreneurial environment within Catalent Biologics, which is making significant investments in people and capabilities. It is a unique opportunity to join a fast-growing business backed by a private company, with strong potential for career development as the business expands. Our Madison team is working on products designed to treat critical conditions such as COVID-19, cancer, autoimmune and fibrotic disorders, HIV, diabetes, heart and lung diseases, and Alzheimer's.

Location:

Madison, WI

100% Onsite

The Role:

• Provide site-level leadership for manufacturing operations at the Madison biologics facility, ensuring safe, compliant, and on-time execution of clinical and commercial manufacturing programs.
• Own manufacturing execution across assigned programs, including safety, quality performance, schedule adherence, cost control, and client commitments.
• Lead a multi-layer manufacturing organization, including managers and supervisors, with accountability for performance management, capability development, engagement, and succession planning.
• Serve as the Manufacturing lead in high-level client interactions, including execution 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 strong standard work, investigation engagement, CAPA effectiveness, and continuous inspection readiness.
• Champion a Manage Through Metrics culture, using KPIs to drive performance, 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.

The Candidate:

• 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.
• Experienced biologics manufacturing leader with deep clinical and commercial CDMO expertise and a proven track record of delivering results.
• Strong knowledge of validation (process, equipment, facility) and cGMP compliance in regulated manufacturing environments.
• Proven ability to lead, develop, and scale high-performing teams in fast-paced, growth-oriented settings.
• Client-focused leader with 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 but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Demonstrated experience supporting scale-up activities (for example, 250 liters to 4000 liters).

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process
• Dynamic, fast-paced work environment
• Generous 401k match and paid time off accrual
• Medical, dental, and vision benefits effective day one of employment

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the…