Senior Scientist QC HPLC (f/m/d)
Core
Lead QC scientist managing deviations, root cause analysis, and analytical method validation for mammalian and mRNA biologics in a GMP environment.
Role type
Senior Quality Control Scientist (Analytical Chemistry)
Builds
GMP-compliant analytical reports, validated methods, and deviation investigations for biologics projects.
Domain
Life Sciences / Biologics / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation investigation, root cause analysis, CAPA implementation, analytical method validation, technical writing, data extraction, process optimization
Preferred skills
HPLC, CE, icIEF, LIMS, CDS, Lean, Six Sigma
Technologies
HPLC, CE, icIEF, LIMS, CDS
Responsibilities
Lead investigations and manage deviations; perform root cause analysis and implement CAPA; coach and mentor junior QC staff; review and evaluate QC analytical results; prepare and approve technical documents for regulatory compliance; support GMP audits; optimize lab processes and workflows; validate and transfer analytical methods.
Seniority
Senior, hands-on IC
