Sr Scientist, Process Development

Responsibilities

• Optimize and characterize cell culture processes for monoclonal antibodies and novel modalities supporting pivotal trials and commercialization
• Lead process risk assessment, characterization studies, and regulatory documentation preparation for BLA submissions
• Design and execute cell culture experiments across multiple bioreactor platforms and scales
• Hire, mentor, and develop direct reports to build high-performing cell culture process development team
• Conduct statistical analyses and modeling to establish process parameter criticality and control strategies

Requirements

• Bachelor's degree with 8+ years experience, or Master's with 6+ years, or PhD/PharmD
• Experience leading pivotal-stage cell culture process development in GMP facilities
• Hands-on bioreactor operations across multiple scales from shake flask to pilot plant
• Strong technical writing and cross-functional collaboration skills
• Experience with design-of-experiments, statistics, and data analysis tools
• Team leadership and talent development capabilities
• Knowledge of cell culture media development and upstream process modeling preferred

Compensation: $169,320–$219,120 base