Manager,QualityControlChemistry

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. **General Description:** Manages all Quality Control (QC) Chemistry Laboratory – Capillary Electrophoresis (CE) activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Chemistry procedures including but not limited to capillary electrophoresis and supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the CE laboratory. This position reports to the Senior Manager QC and is located full-time at the Hopewell, NJ site. **Essential Functions of the Job:** * Lead the QC Chemistry (CE) laboratory daily workflow. * Establish and maintain QC Chemistry (CE) laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. * Manage QC Chemistry (CE) laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. * Ensure QC Chemistry (CE) laboratory compliance with Environmental Health and Safety (EHS) standards. * Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. * Review of laboratory test results, ensuring adherence to Good Documentation Practices. * Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. * Implementation of effective corrective actions and preventive actions (CAPAs). * Participate in internal