QC Chemistry Lead - GMP Biotech Analytics

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

Job summary

BeOne Medicines Ltd. in Hopewell, NJ, seeks a seasoned QC Chemistry analyst to perform routine and non-routine testing using HPLC, UPLC, UV-Vis and related techniques, ensuring timely, compliant results for in-process, release and stability testing in support of GMP manufacturing.

You will review data, investigate OOS events, implement CAPAs, assist with method transfer and validation, and maintain instrument qualification and GMP documentation. Training and audits also form part of the role.

Qualifications

• Bachelor's degree or higher in Chemistry, Biochemistry or Biotechnology related field.
• Minimum 4+ years in FDA-regulated biotechnology/pharma environment.
• Familiar with Waters Empower Chromatography Data System.

Responsibilities

• Perform routine and non-routine testing using HPLC, UPLC, UV-Vis, capillary electrophoresis and related techniques for QC chemistry and raw materials.
• Review, interpret and report analytical data per GMP and internal procedures.
• Investigate OOS events, discrepancies, lab errors and equipment failures; implement CAPAs.
• Participate in transfer and method validation activities; assist protocol execution and report prep.
• Support instrument qualification, SOP generation/revision, test record keeping, and calibration management.
• Train junior analysts and new hires on instrumentation and GMP practices.

Skills

HPLC/UPLC

GMP compliance

Data analysis

CAPA

OOS investigation

Method transfer

SOP writing

Instrument qualification

Training others

Regulatory knowledge

Education

Bachelor's or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline

Tools

Waters Empower Chromatography Data System

Job description

BeOne Medicines Ltd. in Hopewell, NJ, seeks a seasoned QC Chemistry analyst to perform routine and non-routine testing using HPLC, UPLC, UV-Vis and related techniques, ensuring timely, compliant results for in-process, release and stability testing in support of GMP manufacturing.

You will review data, investigate OOS events, implement CAPAs, assist with method transfer and validation, and maintain instrument qualification and GMP documentation. Training and audits also form part of the role.