Catalent, Inc
Director - Process Development, Downstream & Upstream
Madison, WI · Director
Sponsorship not specifiedDetected 7 days ago
Project ManagementStakeholder ManagementProcess ImprovementClinical TrialsGMPCell CultureResearchLeadershipCommunicationMentoring
About the role
- This role is responsible for advancing biologics process development from early-phase programs through commercial readiness while ensuring successful transfer into manufacturing.
- This position provides technical, operational, and people leadership across multiple functions and sites, driving strategic initiatives, process improvements, and organizational performance.
- Define and execute department strategy based on scientific and business priorities.
Responsibilities
- You will deliver scalable upstream and downstream processes, support manufacturing execution, and align cross-functional teams and clients to meet development timelines and business objectives.
- Lead Process Development teams and manage 2-10 direct reports.
- Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
- Partner with clients, project management, and leadership to meet timelines and expectations.
- Lead cross-functional and multi-site strategic initiatives and process improvement efforts.
- Experience in drug development and lifecycle support.
- Ability to manage multiple priorities across sites and functions.
Requirements
- Bachelor's degree in a STEM discipline and 15+ years related experience.
- OR Master's degree in a STEM discipline and 12+ years related experience.
- OR Doctorate degree in a STEM discipline and 8+ years related experience.
- 6+ years of leadership experience.
- Ability to communicate complex technical information to non-technical audiences.
- Experience leading multi-site strategic initiatives.
- Expertise in mammalian cell culture and upstream process development.
- Expertise in downstream process development and process characterization.
- Experience supporting technology transfer and commercial manufacturing readiness.
- Experience with process optimization and continuous improvement initiatives.
Nice to have
- Preferred Skills & Background
Compensation
- Defined career path and annual performance review and feedback process.
Benefits
- Competitive paid time off plus 8 paid holidays.
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