Senior Analyst, QC Chemistry

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. Establishes and implements QC Chemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Chemistry laboratory. This position reports to the QC Sr. 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 large molecule 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 but not limited to 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 and inspections, as needed.
• Train other junior level analysts and new hires on instrumentation, GMP practices, and data analysis.
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.

• 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.
• Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience.
• Working knowledge and experience with analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Hands-on approach, with a 'can do' attitude.
• Ability to prioritize, demonstrating good time management skills.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Interacts 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, pharmaceutical company are required.
• Familiar with Waters Empower Chromatography Data System.
• Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Strong leadership/team management skills and experience.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a 'can do' attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and…