Biochemist
📋 Role Overview & Responsibilities
Title: QC Biochemistry AnalystPosition Type: ContractLocation: Local to Hopewell, NJ
Job Description:Perform 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,
Knowledge, Skills, Abilities:Core Competencies, Knowledge, and Skill RequirementsWorking experience in an FDA-regulated biotechnology, pharmaceutical company are required.Serve as 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.
Education 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.
Computer Skills:Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
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This position is located in Hopewell, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
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