Catalent
Biomanufacturing
Director-Biomanufacturing,Execution
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“Director - Biomanufacturing, Execution at Catalent. Skills: Biomanufacturing Execution, Manufacturing Operations Leadership, Client Delivery, People Leadership, Performance Management, Continuous Improvement, cGMP Compliance, Stakeholder Management. site-level leadership for manufacturing operations. safe, compliant, and on-time execution of clinical and commercial manufacturing programs”
Industry & Context.
risk assessments; issue resolution; translating operational data into insights and decisions
What They're Looking For.
Must Have
Doctorate in a scientific, engineering, or biomanufacturing discipline with a minimum of 8 years of relevant experience, Master’s degree with a minimum of 12 years of relevant experience, 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 understanding of upstream and downstream processing, Working knowledge of process, equipment, and facility validation principles within clinical and commercial operations, 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, business acumen, including understanding the financial impact of manufacturing performance and compliance decisions, Experience building and executing strategic initiatives in complex, cross-functional organizations, Ability to influence across a matrixed organization and align multiple stakeholders with competing priorities
Nice to Have
Demonstrated experience supporting scale-up activities (e. g. , 250L to 4000L) preferred
What You'll Do.
site-level leadership for manufacturing operations
and on-time execution of clinical and commercial manufacturing programs
manufacturing execution across assigned programs
and delivery to client commitments
leading a multi-layer manufacturing organization
performance management
capability development
and succession planning
Manufacturing lead in high-level client-facing interactions
ensuring manufacturing requirements are fully integrated into program strategy
and regulatory readiness
ensuring manufacturing execution aligns with cGMP expectations
establishing and using KPIs to drive performance
right-first-time execution
and continuous improvement
leading and sponsoring continuous improvement initiatives
providing manufacturing leadership during audits and inspections
supporting timely responses and sustained improvements in site readiness
modeling Catalent values
professional client engagement
and a operational mindset across the manufacturing organization
How You'll Work.
Team & Collaboration
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.; Ability to influence across a matrixed organization and align multiple stakeholders with competing priorities.
Communication Scope
client-facing interactions; performance communication; leading difficult conversations with internal teams and external clients; driving alignment to resolution
Process & Methodology
program strategy, validation planning, Experience building and executing strategic initiatives in complex, cross-functional organizations.
Full Job Description
**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 Role** * 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
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