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 Alzheimers.

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 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 Candidate

• 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
• Masters degree with a minimum of 12 years of relevant experience; or
• Bachelors 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 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.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic fast-paced work environment
• Community engagement and green initiatives
• 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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