Senior Manager Process Development (MSAT)
Core
Lead technology transfer, process validation, and optimization for commercial protein biologics production.
Role type
Senior Manager, Process Development (MSAT)
Builds
Commercial protein biologics processes
Domain
Biopharma / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process development, Cell culture, Purification processes, Process scale-up, Technology transfer, Process validation, Troubleshooting, Complex investigation, cGMP compliance, Regulatory filings, Statistical analysis, Analytical methods, Product quality attributes
Preferred skills
Network drug substance team collaboration, Operational aspects of commercial biopharma manufacturing
Responsibilities
Lead projects for biologics technology transfer and process validation, Manage site activities for process optimization and product life cycle management, Manage a team of direct reports in Process Development, Collaborate with cross-functional teams to resolve complex technical challenges, Manage key projects to meet quality, schedule, and cost objectives, Ensure safety and compliance of process development and manufacturing activities, Provide support for regulatory filings, audits, and inspections
Seniority
Senior Manager, hands-on leadership