Wissenschaftlicher Mitarbeiter (m/w/d)
Core
Ensuring quality and timely testing of pharmaceuticals/vaccines, intermediates, and excipients in compliance with drug traffic regulations; implementing new testing methods into routine analytics under GMP conditions.
Role type
Senior IC quality assurance scientist (pharmaceuticals/vaccines)
Builds
Routine analytical testing, method development, validation, and transfer for pharmaceutical and vaccine products
Domain
Life sciences / Pharmaceuticals / Vaccines / Quality Control
Required skills
GMP/GLP expertise, complex deviation handling (OOS/OOT, DEV), CAPA implementation, change control management, method development and validation, statistical analysis, advanced Excel, regulatory knowledge (Gentechnikgesetz/Biostoffverordnung), laboratory leadership
Preferred skills
PhD in Biotechnology/Biology/Biochemistry/Chemistry, 5+ years experience, fluent English, driver's license, experience in infectious disease labs
Technologies
Excel, statistical software, GMP-compliant laboratory information systems
Responsibilities
Review and approve test documentation for samples, reference materials, and reagents; troubleshoot complex deviations and derive corrective actions; create and update SOPs and work instructions; present method development results to customers and authorities; mentor laboratory technicians; coordinate simple change control procedures; perform performance checks on aborted tests.
Seniority
Senior, hands-on IC