Analytical Science and Controls Engineer (m/w/d)
Core
Lead and execute analytical method development, transfer, and validation projects for biopharmaceutical clients, managing international study plans and data analysis.
Role type
Senior IC analytical science and controls engineer
Builds
Analytical methods, study protocols, and validation reports for biopharmaceutical manufacturing
Domain
Biopharmaceuticals / Analytical Chemistry / Process Validation
Required skills
Analytical method development, Method validation, Statistical monitoring, Life cycle management, Stability study design, Comparability study design, Biosimilarity study design, Root cause investigation, Project management, Risk analysis
Preferred skills
Statistical software (Minitab, JMP), LIMS/SAP/Chromeleon, Regulatory guidelines (EMA, FDA, ICH), Process development support
Technologies
Minitab, JMP, Chromeleon, LIMS, SAP
Responsibilities
Lead cross-functional international project teams, Define and coordinate study strategies (validation, stability, comparability), Author risk analyses and study plans, Create analytical specifications and test procedures, Coordinate analytical transfers, Manage sample logistics and data analysis, Participate in root cause investigations
Seniority
Mid-level, hands-on IC
