GxP HPLC Analyst
Core
Develop, validate, and troubleshoot HPLC methods (reverse phase and chiral) for characterizing and assessing purity of non-GMP and GMP radio-labelled APIs.
Role type
GxP HPLC Analyst
Builds
Analytical data and quality records for radio-labelled Active Pharmaceutical Ingredients (APIs)
Domain
Life Sciences / Pharmaceutical / Radiochemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC method development, HPLC method validation, HPLC troubleshooting, GxP compliance, out-of-specification investigation, project coordination, scientific problem solving, mentoring junior scientists
Preferred skills
Analytical Chemistry background, knowledge of chiral chromatography, experience with carbon-14 and tritium labelling, experience in regulated environments
Technologies
HPLC (reverse phase, chiral), radiochemistry synthesis equipment
Responsibilities
Develop and validate HPLC methods, troubleshoot instrumentation and methods, lead out-of-specification investigations, communicate progress and escalate challenges, plan and prioritize work on multiple projects, promote process improvements
Seniority
Mid-level, hands-on IC
