Analyste de laboratoire
Core
Validating, verifying, and transferring analytical methods in the pharmaceutical industry to ensure regulatory compliance.
Role type
Senior analytical method validation and transfer specialist
Builds
Validated analytical methods for pharmaceutical clients
Domain
Pharmaceutical industry / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation, method verification, method transfer, regulatory compliance (USP, EP, JP, ICH), statistical analysis, project planning, resource estimation, risk identification, team leadership, LIMS systems, chromatographic techniques (HPLC, GC), spectroscopic methods (UV, IR)
Preferred skills
Regulatory submission processes, advanced statistical software, Microsoft Office suite
Technologies
HPLC, GC, UV, IR, LIMS
Responsibilities
Lead and supervise method validation, verification, and transfer activities; Ensure compliance with pharmacopoeia and ICH requirements; Develop and execute validation protocols and reports; Perform statistical analysis and interpret validation data; Coordinate cross-functional teams for timely method transfer; Identify and mitigate project risks; Plan and manage resources to meet project deadlines; Communicate project status and risks to stakeholders; Participate in internal and external audits and regulatory inspections
Seniority
Mid-level, hands-on specialist with team leadership
