Director of Biomanufacturing

Director of Biomanufacturing

Position Summary:

Catalents 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 Alzheimers.

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 Masters degree with 12 years of relevant experience; or Bachelors 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 Catalentsponsored 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 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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