Senior QC Chemistry Analyst - GMP Biotech

BeOne Medicines; Hopewell (NJ); On-site; USD 91,000 - 126,000; Full time

Job summary

BeOne Medicines in Hopewell, NJ, is seeking an experienced QC Chemistry professional to support GMP manufacturing, testing and release of materials, intermediates and finished products.

You will perform routine and non-routine analyses (HPLC/UPLC, UV-Vis, GC, TOC, etc.), ensure data integrity under GMP, participate in CAPAs, training, audits, method validation, and contribute to regulatory compliance while reporting to the QC Sr. Manager.

Qualifications

• Bachelor's or above in Chemistry, Biochemistry, or Biotechnology.
• Minimum of 4+ years of FDA-regulated biotech/pharma experience.
• Familiar with USP/EP and cGMP/EU GMP requirements.

Responsibilities

• Perform routine and non-routine testing to support GMP manufacturing.
• Review data according to GMP and internal procedures.
• Lead investigations of OOS events and CAPA implementation.
• Participate in transfers, method validation, and instrument maintenance.
• Train junior analysts on GMP practices and data analysis.

Skills

Leadership

Analytical thinking

Problem solving

GMP compliance

Quality control

Education

Bachelor's or higher in Chemistry / Biochemistry / Biotechnology

Tools

Waters Empower CDS

Job description

BeOne Medicines in Hopewell, NJ, is seeking an experienced QC Chemistry professional to support GMP manufacturing, testing and release of materials, intermediates and finished products.

You will perform routine and non-routine analyses (HPLC/UPLC, UV-Vis, GC, TOC, etc.), ensure data integrity under GMP, participate in CAPAs, training, audits, method validation, and contribute to regulatory compliance while reporting to the QC Sr. Manager.