- Perform QC biochemistry assay validation and transfer activities, including 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.
- Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.
- Participate in internal and external GMP audits where possible.
- Lead method transfer and method validation activities, prepare protocols and reports.
- 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.
- Minimum of 2+ years with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. 5+ years of experience preferred.
- Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
- Serve as subject matter expert for 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.
- Working knowledge with USP/EP and cGMP/EU GMP.
- 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.
- 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.
- MS Office skills (Outlook, Word, Excel, PowerPoint)
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Quality Control Biochemistry Analyst - Hopewell, United States - GroupA
Description
Quality Control Biochemistry AnalystWe are looking for a Quality Control Biochemistry Analyst to join our team on-site in Hopewell, NJ. You will be responsible for QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, company processes and procedures.
Key Responsibilities:
