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
• 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
• 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
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.
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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.
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Review of laboratory test results, ensuring adherence to Good Documentation Practices.
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Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience.
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Working knowledge and experience with analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc.
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Knowledgeable with USP/EP and cGMP/EU GMP regulations.
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Familiar with instrument and equipment validation.
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Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry.
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Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
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Credible and confident communicator (written and verbal) at all levels.
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Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
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Hands-on approach, with a ‘can do’ attitude.
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Ability to prioritize, demonstrating good time management skills.
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Self-motivated, with the ability to work proactively using own initiative.
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Committed to learning and development.
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Interacts with all levels of BeOne employees
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Undertake any other duties as required.