Višji AS&T specialist (m/ž/d)
Core
Lead analytical activities, method development, validation, and transfers within the Analytical Science & Technology (AS&T) lifecycle using GMP expertise.
Role type
Senior AS&T Specialist (Analytical Science & Technology)
Builds
Validated analytical methods and processes for pharmaceutical/biological products
Domain
Life Sciences / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chromatographic methods, Spectroscopic methods, Method validation, Transfer protocols, Data integrity, cGxP compliance, Root cause analysis, Change management, Inspection readiness, Technical reporting
Preferred skills
Strategic planning, Process optimization, Cross-functional collaboration, Stakeholder management
Technologies
HPLC, GC, Mass Spectrometry, NMR, UV-Vis, LIMS, QMS
Responsibilities
Strategically plan and lead analytical activities including method development and validation; Lead complex method validations and transfers; Ensure compliance with cGxP and data integrity standards; Interpret and report on analytical results; Provide technical support for complex issues and change management; Collaborate with internal and external inspections.
Seniority
Senior, hands-on IC
