Senior Quality Control Chemistry Analyst

1d1 day ago

BeiGene

Hopewell, US · Full-time · $89,100 – $124,100

About this role

BeOne Medicines (transitioning from BeiGene) grows rapidly with opportunities for motivated professionals passionate about fighting cancer. Perform QC chemistry laboratory activities to support GMP manufacturing, testing, and release of raw materials, intermediates, and finished products under FDA/EU regulations and company procedures.

Conduct QC chemistry testing including raw material, DS, DP release, and stability testing to ensure timely results supporting manufacturing. Support routine operations such as instrument qualification, maintenance, SOP generation, revision, and record keeping. Manage inventory of reagents and supplies for the laboratory.

Lead investigations of OOS, discrepancies, errors, and failures requiring documented review. Participate in internal and external GMP audits as needed. Train junior analysts and new hires while serving as subject matter expert in testing areas.

Lead method transfer and validation activities, preparing protocols and reports. Interact with all levels of BeOne employees. Undertake additional duties in a collaborative environment focused on affordable medicines for patients worldwide.

Requirements

6+ years of experience with general education, 4+ years with scientific degree in chemistry, biochemistry, biotechnology or related, 2+ years with PhD
4+ years working experience in an FDA-regulated biotechnology or pharmaceutical company preferred
Working knowledge and experience with chemistry analytical methods such as HPLC, UPLC, GC, CE, IEF, TOC, UV, FTIR/NIR/Raman, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods
Working knowledge with USP/EP and cGMP/EU GMP
Familiar with instrument and equipment validation
Strong leadership and team management skills and experience
Credible and confident communicator written and verbal at all levels
Strong analytical and problem-solving ability

Responsibilities

Perform QC chemistry laboratory testing for raw material, DS, DP release and stability testing to support manufacturing operations
Support routine operations including instrument qualification and maintenance, SOP generation and revision, testing record keeping
Manage inventory of reagents and supplies for the laboratory
Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action
Participate in internal and external GMP audits as needed
Lead method transfer and method validation activities, prepare protocols and reports
Train junior level analysts and new hires
Serve as subject matter expert in one or more areas of required testing