Senior Analyst, QC Chemistry

General Description:

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.

Essential Functions of the Job:

• 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.

Supervisory Responsibilities:

• 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 development.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Ability to work on a computer for extended periods of time

Travel: Must be willing to travel approximately 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.