Senior QC Chemist: Capillary Electrophoresis & GMP Compliance

Regulatory Jobs; Hopewell (NJ); On-site; USD 91,000 - 126,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

FSA/HSA

Life Insurance

Paid Time Off

Wellness Program

Equity Awards

Job summary

BeOne Medicines Ltd. seeks an experienced QC Chemist to perform capillary electrophoresis-based testing in a GMP-regulated QC Chemistry lab supporting manufacturing and release of monoclonal antibodies. You will review data, troubleshoot CE methods, and participate in investigations and CAPAs to ensure compliant results.

The role requires a 4+ year track record in FDA-regulated biotech, familiarity with Waters Empower CDS, and strong analytical capabilities. Travel ~10% may be required.

Qualifications

• Bachelor’s or higher in Chemistry, Biochemistry, or Biotechnology.
• Minimum 4+ years of FDA-regulated biotech/pharma experience.
• Familiar with Waters Empower Chromatography Data System.
• Experience with method validation and instrument qualification.
• Knowledge of USP/EP and cGMP/EU GMP regulations.
• Strong analytical and problem-solving abilities with attention to detail.
• Excellent written and verbal communication, team collaboration.

Responsibilities

• Perform QC testing using capillary electrophoresis (CE-SDS, CZE, icIEF) for release and stability.
• Review and report analytical data in compliance with GMP/internal procedures.
• Lead troubleshooting for CE methods/instrumentation.
• Conduct investigations for OOS, deviations, and invalid assays.
• Implement CAPAs and participate in method transfer and validation activities.
• Support instrument qualification, SOP updates, and record keeping.
• Maintain calibrated equipment and coordinate with metrology/vendors.
• Manage lab reagent inventories and participate in GMP audits.

Skills

Analytical thinking

Problem solving

Team leadership

Communication

Attention to detail

Self-motivation

Time management

Capillary electrophoresis knowledge

Education

Bachelor's in Chemistry/Biochemistry/Biotechnology

Tools

Waters Empower CDS

Instrument validation

HPLC/GC/TOC methods

Job description

BeOne Medicines Ltd. seeks an experienced QC Chemist to perform capillary electrophoresis-based testing in a GMP-regulated QC Chemistry lab supporting manufacturing and release of monoclonal antibodies. You will review data, troubleshoot CE methods, and participate in investigations and CAPAs to ensure compliant results.

The role requires a 4+ year track record in FDA-regulated biotech, familiarity with Waters Empower CDS, and strong analytical capabilities. Travel ~10% may be required.