Senior QC Chemistry Analyst: GMP Lab Expert

BeOne Medicines; Pennington (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

BeOne Medicines in Hopewell, NJ, seeks a QC Chemistry specialist to support GMP manufacturing, testing, and release of materials and products. The role involves HPLC/UPLC methods, data review, and CAPA-driven improvements in a fast-paced lab.

Responsibilities include instrument maintenance, SOP updates, test record keeping, and internal/external GMP audits. Candidates should have 4+ years in FDA-regulated biotech/pharma environments and strong analytical skills.

Qualifications

• Experience in FDA-regulated biotech/pharma environments.
• Proficiency with GMP documentation and data integrity.
• Ability to lead investigations of OOS events and CAPAs.

Responsibilities

• Perform routine and non-routine testing using HPLC/UPLC and other techniques to ensure timely test results.
• Review and report analytical data per GMP and internal procedures.
• Investigate OOS events, discrepancies, and equipment issues; implement CAPAs.
• Participate in transfer and method validation activities, including protocol execution and reporting.
• Maintain instrument qualification, SOPs, and test record keeping; manage lab inventory.
• Train junior analysts and act as subject matter expert in testing areas.

Skills

HPLC

UPLC

UV-Vis

Capillary electrophoresis

GMP

OOS investigation

CAPA

Method transfer

Method validation

SOP generation

Instrument qualification

Documentation practices

QA/QC in biopharma

Education

Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology

Tools

Waters Empower Chromatography Data System

Job description

BeOne Medicines in Hopewell, NJ, seeks a QC Chemistry specialist to support GMP manufacturing, testing, and release of materials and products. The role involves HPLC/UPLC methods, data review, and CAPA-driven improvements in a fast-paced lab.

Responsibilities include instrument maintenance, SOP updates, test record keeping, and internal/external GMP audits. Candidates should have 4+ years in FDA-regulated biotech/pharma environments and strong analytical skills.