Department: Quality Control

Reports To: QC Supervisor / Manager

Position Type: Full-Time

General Description:

BeiGene is seeking a QC Chemistry Analyst specialized in raw materials to join our quality control team. This role involves performing QC sampling and chemistry testing of raw materials such as starting materials, excipients, primary packaging materials, and manufacturing water under FDA/EU regulations and BeiGene procedures to support GMP manufacturing operations.

Essential Functions:

• Conduct compendial (USP/EP) testing of raw materials to ensure compliance with specifications.
• Perform sampling and physiochemical testing of raw materials to support manufacturing and ensure timely reporting of results.
• Manage routine operations including instrument qualification and maintenance, SOP and specification documentation, raw material sampling and testing, and record-keeping.
• Assist in QC sample management, including receipt of in-process samples and issuance of controlled documentation.
• Oversee the receipt and inventory management of laboratory reagents and supplies.
• Participate in internal and external GMP audits as necessary.
• Perform other duties as assigned to support QC and manufacturing operations.

Required Skills and Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Biotechnology, or a related field.
• Experience in an FDA-regulated biotechnology or pharmaceutical environment.
• Proficient in raw material sampling and testing within a cleanroom setting.
• Skilled in physiochemistry analytical methods such as HPLC, GC, TOC, FTIR/NIR/Raman, Karl Fischer titration, osmolality, melting point, optical rotation, and wet chemistry.
• Familiarity with USP/EP standards and cGMP/EU GMP regulations.
• Experience with instrument and equipment validation.
• Excellent communication, analytical, and problem-solving skills.
• A proactive approach to work, with a 'can do' attitude and the ability to prioritize tasks effectively.
• Strong attention to detail and capability to work accurately in a high-demand environment.
• Self-motivated with a commitment to personal and professional development.

Computer Skills:

• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint) is required.