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General Description:

Perform QC Biochemistry laboratory activities with a primary focus on capillary electrophoresis techniques to support GMP manufacturing, testing, and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, and BeOne Medicines’ processes and procedures.

Essential Functions of the job:

+ Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC biochemistry 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.

+ 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, 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, as needed.

+ Train other junior level analysts and new hires on CE instrumentation, GMP practices, and data analysis.

+ Serving as subject matter expert in one or more areas of required testing.

+ Undertake other duties as required.

Core** **Competencies** **, Knowledge, and Skill Requirements

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

+ Minimum of 4+ years of GMP testing using capillary electrophoresis techniques in an FDA-regulated biotechnology, pharmaceutical company is required.

+ Working knowledge and experience with biochemistry analytical methods such as residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), capillary isoelectric focusing (cIEF), etc.

+ Familiar with Waters Empower Chromatography Data System.

+ Working knowledge with USP/EP and cGMP/EU GMP regulations.

+ Familiar with instrument and equipment validation.

+ 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.

Significant Contacts

+ Interacts with all levels of BeOne employees.

Supervisory Responsibilities:

+ N/A

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.