Head of Manufacturing Science at Round Lake
Core
Strategic and technical leadership for all Manufacturing Sciences activities supporting aseptic fill-finish operations for plasma-derived therapies (Flexbumin®) at the Round Lake site.
Role type
Senior leadership manufacturing science manager (plasma-derived biologics)
Builds
Reliable supply of Flexbumin® (Human Albumin) via proprietary GALAXY sterile filling technology
Domain
Biologics / Plasma-derived therapies / Aseptic fill-finish
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing operations)
Required skills
Aseptic processing, fill-finish manufacturing, process validation, continued process verification (CPV), lifecycle management, root cause analysis, regulatory compliance (cGMP), team leadership, process optimization, Lean/Six Sigma
Preferred skills
Plasma-derived therapies experience, albumin manufacturing, sterile filling technologies, statistical process control, data analytics tools
Technologies
GALAXY sterile filling technology
Responsibilities
Provide technical oversight and approval of process validation strategies, CPV, and technology transfers; Lead complex troubleshooting and root cause investigations for manufacturing deviations; Drive process improvement strategies using data-driven methodologies; Ensure compliance with global regulatory requirements during inspections; Lead, coach, and develop a team of scientists and engineers; Partner with global technical functions to align process strategies.
Seniority
Senior, hands-on IC with strategic leadership scope