Process Manager (m/w/d) DSP
Core
Responsible for Downstream Process Development and Scale-Up of APIs for biopharmaceutical customers across the product lifecycle.
Role type
Senior Process Scientist (Downstream)
Builds
Scalable downstream processes for biopharmaceuticals
Domain
Biopharmaceutical manufacturing / CDMO
Required skills
Downstream process development, chromatography, filtration techniques, Quality-by-Design (QbD), Design-of-Experiments (DoE), statistical modeling, regulatory guidelines, CMC dossier review, cross-functional team leadership
Preferred skills
AI tools for data automation, Upstream processing basics, project management
Technologies
JMP
Responsibilities
Design and develop scalable downstream processes from lab to commercial scale, transfer customer processes to company format, lead laboratory staff and process engineers, review CMC regulatory dossiers, participate in customer audits and regulatory inspections
Seniority
Senior, hands-on IC
