Job Title: Analyst, QC Biochemistry- Princeton NJ
Department: Quality Control; Reports to: QC Manager

General Summary:
The QC Biochemistry Analyst is responsible for performing laboratory activities to support the GMP-compliant testing, release, and stability of biologic products, including monoclonal antibodies. This role ensures testing is conducted in alignment with FDA, EU, and international regulatory standards, as well as internal quality systems and procedures.

Technical Skills and Knowledge:

• Hands-on experience with analytical techniques such as:

  • Quantitative PCR (qPCR) for residual DNA
    

  • Host Cell Protein (HCP) ELISA
    

  • Residual Protein A ELISA
    

  • Binding Activity ELISA
    

  • Capillary Electrophoresis (CE)
    

  • Capillary Isoelectric Focusing (cIEF)
    

  
  

• Strong understanding of cGMP, FDA, EU GMP, and USP/EP regulatory requirements.
  

• Familiarity with equipment and instrument validation processes.

Key Responsibilities:                                                                                                                                       

• Perform QC Biochemistry testing on drug substance (DS), drug product (DP), and stability samples to support lot release and manufacturing timelines.
  

• Maintain accurate and timely documentation of test results in accordance with cGMP and GDP guidelines.
  

• Conduct and support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and invalid assays.
  

• Implement effective corrective and preventive actions (CAPAs) based on root cause analysis.
  

• Participate in internal and external GMP audits and inspections as required.
  

• Support method transfers and validation activities, including protocol generation, execution, and reporting.
  

• Act as a subject matter expert (SME) in one or more core biochemical assay areas.

Required Qualifications:

• Bachelor’s degree (or higher) in Biochemistry, Chemistry, Biotechnology, or a related scientific discipline.
  

• Minimum 2 years of experience in a QC or analytical laboratory environment within the biotech or pharmaceutical industry under FDA regulations.
  

• 5+ years of relevant experience accepted in lieu of higher education.

Core Competencies:

• Exceptional attention to detail and commitment to data integrity.
  

• Team-oriented with leadership capabilities and a proactive, hands-on approach.
  

• Flexible and adaptable to changing priorities or responsibilities.

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