Director - Biomanufacturing, Execution

Title:

Director – Biomanufacturing, Execution

Location:

Madison, WI Position Summary

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

• The Director, Biomanufacturing Execution provides site-level leadership for manufacturing operations at the Madison biologics facility. This role owns safe, compliant, and on‑time execution of clinical and commercial manufacturing programs in a fast‑paced CDMO environment, with direct accountability for people leadership, performance, and client delivery.
• Owns manufacturing execution across assigned programs, including safety, quality performance, schedule adherence, cost control, and delivery to client commitments.
• Leads a multi‑layer manufacturing organization, including managers and supervisors, with full accountability for performance management, capability development, engagement, and succession planning.
• Serves as the Manufacturing lead in high‑level client‑facing interactions, including execution strategy, manufacturing readiness, risk assessments, issue resolution, and ongoing performance communication.
• Partners closely with MST, Quality, PD, Engineering & Facilities, and Project Management to ensure manufacturing requirements are fully integrated into program strategy, validation planning, and regulatory readiness.
• Ensures manufacturing execution aligns with cGMP expectations through strong standard work, investigation engagement, CAPA effectiveness, and continuous inspection readiness.
• Champions a Manage Through Metrics culture, establishing and using KPIs to drive performance, right‑first‑time execution, deviation reduction, and continuous improvement.
• Leads and sponsors continuous improvement initiatives that improve efficiency, reduce waste, strengthen compliance, and positively impact COGS and financial performance.
• Provides manufacturing leadership during audits and inspections, supporting timely responses and sustained improvements in site readiness.
• Models Catalent values, professional client engagement, and a strong operational mindset across the manufacturing organization.

• The successful candidate is an experienced manufacturing leader with deep clinical and commercial biologics expertise, strong people leadership capability, and a proven ability to deliver results in a client‑focused CDMO environment.
• Doctorate in a scientific, engineering, or biomanufacturing discipline with a minimum of 8 years of relevant experience; or
• Master’s degree with a minimum of 12 years of relevant experience; or
• Bachelor’s degree with a minimum of 15 years of relevant experience.
• Minimum of 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.
• Demonstrated experience supporting scale‑up activities (e.g., 250L to 4000L) preferred.
• Working knowledge of process, equipment, and facility validation principles within clinical and commercial operations.
• Strong understanding and application of cGMP requirements in regulated manufacturing environments.
• Proven ability to lead and develop manufacturing leaders and teams in a fast‑paced, growth‑oriented CDMO setting.
• Core experience working directly with clients, including managing expectations, resolving execution issues, and communicating risk and readiness.
• Skilled at leading difficult conversations with internal teams and external clients and driving alignment to resolution.
• Demonstrated ability to translate operational data into insights and decisions.
• Strong business acumen, including understanding the financial…