Director, Bioprocess / Process Development - Pivotal Drug Substance

This director-level role oversees bioprocess development and scale-up for drug substances across multiple sites, leading a team of 30+ scientists and engineers. Responsibilities include managing cell culture and purification processes for late-stage biologics programs, directing regulatory submissions, and advancing commercial manufacturing strategies. A doctorate with 4+ years of process development experience, or a master's degree with 8+ years, is required.

Responsibilities

• Lead multi-site organization of 30+ scientists and engineers across cell culture and purification disciplines
• Recruit, develop, and retain diverse team; manage portfolio prioritization and organizational resourcing
• Advance drug substance processes through commercial development, characterization, lifecycle management, and control strategies
• Partner with engineering and manufacturing collaborators to enable process transfer and commercialization
• Author and review global regulatory filings and respond to regulatory agency inquiries

Requirements

• Doctorate degree and 4+ years process development experience, or equivalent education/experience combination
• 4+ years directly managing people and leading teams or programs
• PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related field preferred
• 10+ years biopharmaceutical process development experience preferred
• Deep expertise in cell culture bioreactor or downstream purification processes
• Strong understanding of late-stage biologics development, process validation, and regulatory interactions
• Demonstrated statistical analysis, technical decision-making, and senior-level communication skills