Manufacturing Process Manager
Core
Lead process development, scale-up, and manufacturing optimization for active pharmaceutical ingredients in a GMP environment.
Role type
Manufacturing Process Manager (Process Development & Scale-up)
Builds
Robust manufacturing processes for active pharmaceutical ingredients
Domain
Pharmaceutical manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process development, scale-up, manufacturing optimization, GMP compliance, regulatory compliance (FDA/EMA/ISO), statistical analysis, DOE, troubleshooting, SOP development, validation protocols, data analysis, process modeling, technical writing
Preferred skills
Lean/Six Sigma methodologies, advanced degree, team leadership, cross-functional collaboration
Technologies
statistical software, business applications
Responsibilities
Lead complex projects and drive technology transfer initiatives, collaborate with R&D/Quality/Engineering/Production to maintain quality standards, troubleshoot complex process issues and implement corrective actions, develop and support team members, ensure compliance with regulatory requirements
Seniority
Senior, hands-on IC