This role involves performing routine and non-routine testing using capillary electrophoresis techniques to support the release of monoclonal antibodies under FDA and EU regulations
Job Summary
This role involves performing routine and non-routine testing using capillary electrophoresis techniques to support the release of monoclonal antibodies under FDA and EU regulations.
The successful candidate will lead troubleshooting efforts for analytical methods, conduct laboratory investigations including OOS and deviations, and implement corrective actions.
BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards.
Matching Summary
This role involves performing routine and non-routine testing using capillary electrophoresis techniques to support the release of monoclonal antibodies under FDA and EU regulations.
Salary
Base: $90,900.00 - $125,900.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off
Skills & Requirements
Must-have
Capillary Electrophoresis (CE-SDS, CZE, icIEF)
FDA/EU GMP regulations compliance
OOS and Out of Trend investigations
Waters Empower Chromatography Data System
Method validation and transfer activities
Nice-to-have
Strong analytical and problem-solving ability
Subject matter expert in CE instrumentation
Collaborative spirit and team player
Ability to prioritize in busy environments
Self-motivated with proactive initiative
Key Requirements
Bachelor's degree in Chemistry or related field
Minimum 4+ years experience in FDA-regulated biotech/pharma
Working knowledge of USP/EP and cGMP/EU GMP regulations