• Senior Analyst, QC Biochemistry

    BeOne Medicines (Pennington, NJ)


    General Description:

    Perform QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures.

    Essential Functions of the job:

    + Perform QC biochemistry laboratory testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

    + Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.

    + Manage inventory of reagents and supplies for the laboratory.

    + Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.

    + Implement corrective actions and preventive actions (CAPAs).

    + Participate in internal and external GMP audits, as needed.

    + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.

    + Train other junior level analysts and new hires.

    + Subject matter expert in one or more areas of required testing.

    + Undertake any other duties as required.

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

    + 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.

    + 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

    Supervisory Responsibilities:

    + N/A

    Computer Skills:

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

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

    **Other Qualifications:** Interacts with all levels of BeOne employees

    Education Required:

    + Bachelor’s Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required.

    + Master’s degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 2+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are preferred.

    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.