Director - Biomanufacturing, Execution
On-site · Madison, Wisconsin, United States
Job Summary
Directs site-level manufacturing execution at the Madison biologics facility, ensuring safe, compliant, on-time delivery of clinical and commercial programs in a fast-paced CDMO environment. 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 with accountability for performance management, capability development, engagement, and succession planning. Serves as the Manufacturing lead in client-facing interactions, partnering with MST, Quality, PD, Engineering & Facilities, and Project Management to ensure manufacturing requirements are integrated into program strategy, validation planning, and regulatory readiness. Champions a Manage Through Metrics culture, establishing KPIs to drive right-first-time execution, deviation reduction, and continuous improvement. Provides manufacturing leadership during audits and inspections and supports timely responses and sustained improvements in site readiness.
Required Qualifications
- 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.
- 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.
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