Senior Analyst - QC Chemistry

1d1 day ago

BeiGene

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

About this role

BeOne continues to grow rapidly with opportunities for experienced professionals passionate about fighting cancer. Perform QC Chemistry laboratory activities focused on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of monoclonal antibodies under FDA/EU regulations and company procedures.

Conduct routine and non-routine testing using CE-SDS, CZE, and icIEF in the QC Chemistry lab to generate compliant in-process, release, and stability results. Review, interpret, and report analytical data per GMP regulations. Lead troubleshooting for CE methods and instrumentation.

Handle laboratory investigations including OOS, out-of-trend, deviations, and invalid assays. Implement CAPAs and participate in method transfers and validations. Support operations like instrument qualification, SOP revisions, and inventory management while training junior analysts.

Serve as subject matter expert in testing areas and interact with all levels of BeOne employees. Participate in GMP audits and maintain qualified equipment. Undertake additional duties to advance manufacturing support in a collaborative environment.

Requirements

Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline
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

Responsibilities

Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) to support manufacturing
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, execution, and reporting
Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis
Maintain equipment in a qualified and calibrated state and manage laboratory inventory