Chemist

Work Location: Mercer County, New Jersey Summary: Perform QC Chemistry 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 internal processes and procedures. Responsibilities: Perform routine and non-routine testing using capillary electrophoresis techniques (e.g., CE-SDS, CZE, icIEF) in the QC Chemistry 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. Qualifications: Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Minimum of 4+ years of working experience in an FDA-regulated biotechnology or pharmaceutical company. CE experience is an absolute must have. Familiar with Waters Empower Chromatography Data System. Familiar with instrument and equipment validation. Working knowledge with USP/EP and cGMP/EU GMP regulations. Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc. 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 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. Must be willing to travel approximately 10%. Ability to work on a computer for extended periods of time. #J-18808-Ljbffr