Manager - Process Development, Downstream

Catalent · Madison, WI

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Role summary

Catalent seeks a downstream process development manager to lead late-stage development and characterization for protein biologics in Madison, Wisconsin. The role combines technical expertise in unit operations with cross-functional team leadership, supporting programs from clinical through commercial manufacturing stages.

What they're looking for

PhD in Biotechnology or related field with 4+ years laboratory/leadership experience; or M.S. with 8+ years; or B.S. with 10+ years
Minimum 4 years leadership experience directing personnel and organizational groups
Expertise in downstream unit operations: chromatography, filtration, viral clearance, formulation for protein biologics
Experience with process characterization, validation, CPP/CQA identification, and quality-by-design principles
Knowledge of cGMP compliance, data integrity, and regulatory documentation for biologics
Proficiency with statistical tools and design of experiments for process robustness
Experience liaising with internal and external clients, customers, and cross-functional teams

What you'll be doing

Supervise daily work activities of assigned team, ensuring training, guidance, and technical problem-solving
Hire, develop, evaluate, and mentor direct reports and people leaders on leadership fundamentals
Lead late-phase process development, characterization, and PPQ readiness activities for protein biologics
Author and review technical documents including SOPs, protocols, and regulatory-supporting reports
Identify and implement new technologies for continuous improvement and transition to cGMP manufacturing

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