Senior Process Expert (m/f/d)
Core
Design and realize a next-generation biologics manufacturing facility, translating operational requirements into robust, scalable, GMP-compliant process solutions.
Role type
Senior Process Expert (Manufacturing SME)
Builds
New production platform for biologics
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
recombinant protein manufacturing, microbial fermentation, downstream processing, process engineering, GMP compliance, facility design, commissioning, qualification, process validation, technology transfer, process risk management
Preferred skills
large capital investment projects, greenfield/brownfield pharmaceutical projects, operational excellence methodologies
Technologies
process equipment, manufacturing processes
Responsibilities
Act as Manufacturing SME for process equipment and operational requirements; Shape facility design by embedding operational and GMP requirements; Drive manufacturing readiness via commissioning and validation; Collaborate with Engineering, Quality, and Automation to develop efficient solutions; Identify process risks and develop mitigation strategies; Support technology transfer; Coach future operations teams; Contribute to project governance and decision-making.
Seniority
Senior, hands-on IC
