Senior Analyst, QC, US Site; Hopewell, NJ

Senior Analyst, QC, US Site (Hopewell, NJ)

Join to apply for the Senior Analyst, QC, US Site (Hopewell, NJ) role at BeOne Medicines
.

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.

Perform QC Chemistry laboratory 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. Establish and implement QC Chemistry procedures and support regulatory compliance inspections. Ensure efficient and effective day-to-day operations of the Chemistry laboratory. This position reports to the QC Manager and is located full time at the Hopewell, NJ site.

• Perform routine and non-routine testing using HPLC, UPLC, UV-Vis, capillary electrophoresis, and other techniques (PS-20, HPLC-SEC, TOC, Conductivity, CZE, etc.) in the QC Chemistry and Raw Materials laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of manufacturing operations.
• Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
• Support routine operations, including instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
• Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
• Manage inventory of reagents and supplies for the laboratory.
• Participate in internal and external GMP audits, as needed.
• Train other junior level analysts and new hires on instrumentation, GMP practices, and data analysis.
• Serve as subject matter expert in one or more areas of required testing.

• 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 laboratory test results, ensuring adherence to Good Documentation Practices.
• Possess expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands‑on laboratory experience.
• Maintain working knowledge and experience with analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc.
• Be knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Possess expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry.
• Have an impressive, demonstrable track record and skills/experience gained within a similar position at a similar level.
• Be a credible and confident communicator (written and verbal) at all levels.
• Exhibit strong analytical, problem‑solving ability with excellent attention to detail in a busy and demanding environment.
• Maintain a hands‑on approach, with a ‘can do’ attitude.
• Prioritize and demonstrate good time‑management skills.
• Show self‑motivation and a proactive use of own initiative.
• Commit to learning and development.
• Interact with all levels of BeOne employees.
• Undertake any other duties as required.

• 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 and have a strong knowledge of USP/EP and cGMP/EU regulations.
• Strong leadership and team‑management skills.
• Credible and…