Senior Analyst - QC Chemistry

21h21 hours ago

BeiGene

Hopewell, US · Full-time · $90,900 – $125,900

About this role

BeOne continues to grow rapidly with challenging opportunities for experienced professionals who share a passionate interest in fighting cancer. The Senior Analyst performs QC Chemistry laboratory activities focused on capillary electrophoresis techniques. This role supports GMP manufacturing, testing, and release of monoclonal antibodies under FDA/EU regulations.

Daily responsibilities include routine and non-routine testing using CE-SDS, CZE, and icIEF to generate compliant in-process, release, and stability results. Analysts review, interpret, and report data per GMP standards while leading troubleshooting for CE methods and instruments. Laboratory investigations cover OOS, deviations, and invalid assays.

The role involves interacting with all levels of BeOne employees and participating in internal/external GMP audits. Support routine operations like instrument qualification, SOP revisions, and inventory management. Maintain equipment in qualified state, coordinating with metrology or vendors.

Opportunities include leading CAPAs, method validation, and protocol execution. Train junior analysts on CE instrumentation, GMP practices, and data analysis. Serve as subject matter expert in testing areas to advance manufacturing support.

Requirements

Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company
Familiar with Waters Empower Chromatography Data System
Familiar with instrument and equipment validation
Working knowledge with USP/EP and cGMP/EU GMP regulations
Strong analytical and problem-solving ability
Credible and confident communicator (written and verbal) at all levels
Excellent attention to detail, with the ability to work accurately in a busy environment
Self-motivated, with the ability to work proactively using own initiative

Responsibilities

Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF)
Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures
Lead troubleshooting efforts for analytical methods and instrumentation related to CE
Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays
Implement corrective actions and preventive actions (CAPAs)
Participate in transfer and method validation activities, including protocol preparation and execution
Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis
Serve as subject matter expert in one or more areas of required testing