Manager - Process Development, Downstream
Core
Lead late-stage process development and process characterization activities for protein biologics, ensuring robust process understanding and regulatory-ready documentation from clinical through commercial stages.
Role type
Manager, Downstream Process Development
Builds
Protein biologics for treating COVID-19, cancer, autoimmune, fibrotic, blood disorders, HIV, diabetes, heart/lung diseases, and Alzheimer's
Domain
Biopharmaceutical manufacturing / Downstream processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream unit operations (chromatography, filtration, viral clearance, formulation), Quality-by-Design (QbD) principles, GMP/GDP compliance, Technology transfer to cGMP manufacturing, Process characterization and validation, Statistical and experimental design (DoE), Cross-functional leadership, Team management and mentoring
Preferred skills
Lean principles, 5S, Continuous improvement initiatives
Technologies
Chromatography, Ultrafiltration/Diafiltration (UF/DF), Normal flow filtration, Viral clearance systems, Scale-down models
Responsibilities
Supervise team daily activities and workload; Hire, train, motivate, lead, and evaluate staff; Mentor people leaders on leadership fundamentals; Ensure regulatory compliance and data integrity; Interact with customers as first line of escalation; Identify and implement new technology/instrumentation for productivity improvements; Author and review technical documents (SOPs, protocols, reports); Collaborate with cross-functional groups (Project Management, Manufacturing, MS&T, Quality, Analytical Development); Coach direct reports on performance and career development
Seniority
Manager, hands-on technical leadership with people management
