Manager - Process Development, Downstream

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.

Responsibilities

• 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

Requirements

• 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