Laborant QK Biosimilars (w/m/d)
Core
Perform and evaluate complex physicochemical and chromatographic analyses in compliance with GMP regulations for biosimilars.
Role type
Senior QC Laboratory Analyst (Biosimilars)
Builds
Analytical data and quality reports for biosimilar drug products
Domain
Pharmaceutical / Biotechnology / Quality Control
Required skills
HPLC/UPLC, SEC-HPLC, UV/Vis, CE, cIEF, GMP compliance, OOS/OOT/OOE investigation, CAPA management, method validation, method transfer, SOP development, root cause analysis, LIMS
Preferred skills
Mentoring lab staff, audit support, process optimization, digitalization solutions
Responsibilities
Conduct and evaluate physicochemical and chromatographic analyses; Investigate OOS/OOT/OOE results and deviations; Plan and document method validations, verifications, and transfers; Develop and revise SOPs and GMP documentation; Support lab staff training and mentorship; Participate in process optimization and technology introduction
