Process Expert (m/f/d)
Core
Process expert establishing and operating next-generation manufacturing processes for plasmid DNA, mRNA, and lipid nanoparticle (LNP) technologies.
Role type
Senior IC process expert (nucleic acid manufacturing)
Builds
Innovative therapies (plasmid DNA, mRNA, LNPs) for patients worldwide
Domain
Biopharmaceutical manufacturing / Nucleic Acid Facilities
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process lifecycle management, deviation management, CAPA implementation, change control, root cause analysis, risk assessment, data interpretation, technical training
Preferred skills
plasmid DNA/mRNA/LNP manufacturing experience, process validation, technology transfer, process characterization, SAP/MES/eQMS systems, EU GMP requirements, data integrity principles
Technologies
SAP, MES, eQMS
Responsibilities
Serve as process owner for nucleic acid manufacturing, provide real-time technical support to GMP operations, analyze process performance data, lead investigations and CAPA implementation, author GMP documentation, support process validation and qualification, drive operational excellence, collaborate on technology transfers, support health authority inspections, train manufacturing personnel
Seniority
Senior, hands-on IC