Biochemist

2 weeks ago

East Brunswick, United States Kelly Science, Engineering, Technology & Telecom Full time

Job Title: Senior QC Biochemistry Scientist


Essential Functions:

  • Lead and execute QC biochemistry assay validation and transfer activities, including testing for Drug Substance, Drug Product release, and stability testing, ensuring timely generation and reporting of test results to support manufacturing operations.
  • Support routine operations, including instrument qualification and maintenance, SOP generation and revision, testing record keeping, and more.
  • Manage inventory of reagents and supplies for the laboratory, ensuring uninterrupted workflow.
  • Lead investigations of OOS, discrepancies, errors, and failures, implementing necessary corrective actions.
  • Participate in internal and external GMP audits to uphold quality standards.
  • Lead method transfer and method validation activities, preparing protocols and reports.
  • Train junior-level analysts and new hires, fostering a culture of continuous learning and development.



Core Competencies, Knowledge, and Skills:

  • Working knowledge and experience in an FDA-regulated biotechnology or pharmaceutical company.
  • Expertise in residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis (cIEF), including qualification, assay validation, and transfer activities.
  • Familiarity with USP/EP and cGMP/EU GMP and ICH guidelines.
  • Strong leadership and team management skills, with the ability to inspire and motivate others.
  • Excellent communication skills, both written and verbal, with the ability to convey complex information effectively.
  • Strong analytical and problem-solving abilities, with a hands-on approach and a 'can do' attitude.
  • Exceptional attention to detail, with the ability to prioritize tasks and manage time effectively in a fast-paced environment.

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