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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 5-7 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

Computer Skills:

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

Travel:

+ Must be willing to travel approximately 10%.

+ Ability to work on a computer for extended periods of time.

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.