Senior QC Chemistry Analyst
hace 3 días
Hopewell
Job Title: Senior Analyst, QC Chemistry 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., • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)., • Must be willing to travel approximately 10%., • Ability to work on a computer for extended periods of time.
