AS&T specialist (m/ž/d)
Core
Plan, execute, and optimize analytical and stability activities to ensure reliable and compliant pharmaceutical manufacturing processes.
Role type
Analytical and Stability Specialist (AS&T)
Builds
Pharmaceutical products and analytical methods
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chromatographic methods, Spectroscopic methods, cGxP compliance, Data integrity principles, GMP, Validation, Qualification, Calibration, Stability study coordination, Statistical analysis
Preferred skills
Transfer project support, Method development, Incident management, Quality culture promotion
Technologies
HPLC, GC, Mass Spectrometry, LIMS, Statistical software
Responsibilities
Plan, execute, and document analytical and stability activities; Support production transfer projects and lead method transfers; Perform product, process, and analytical validations; Plan and execute equipment qualifications and calibrations; Implement new technologies and improve laboratory processes; Coordinate stability studies and sample collection; Collaborate on inspections and quality incident handling
Seniority
Individual Contributor, Entry to Mid-level