Department: Quality Control

Reports To: QC Chemistry Manager

Position Type: Full-Time

Travel Requirements: Approximately 10%

Job Summary:

BeiGene is seeking a QC Chemistry Specialist with a strong background in analytical chemistry to support GMP manufacturing, testing, and release of biological products, specifically monoclonal antibodies. The successful candidate will be responsible for assay validation, transfer activities, and routine operational support within our QC chemistry laboratory. This role demands adherence to FDA/EU and other international regulatory standards, making contributions essential to the continued success and compliance of our operations.

Essential Functions:

• Perform QC chemistry assay validation and transfer activities for DS, DP release, and stability testing to support manufacturing operations.
• Ensure timely generation and reporting of test results.
• Maintain laboratory instruments, generate and revise SOPs and specifications, and manage laboratory inventory.
• Conduct laboratory investigations (OOS, Out of Trend, deviations, invalid assays) and implement corrective actions.
• Participate in internal and external GMP audits as required.
• Engage in method transfer and validation activities, including preparation and execution of protocols and reporting.

Required Skills and Qualifications:

• Bachelor's or Master's degree in Chemistry, Biochemistry, Biotechnology, or related field.
• Minimum 2 years of experience in an FDA-regulated biotechnology or biopharmaceutical company.
• Proficiency in analytical methods for biological products, including HPLC, UPLC, CCIT, Sub-visible Particles, N-glycan analysis, and UV spectrophotometry.
• Familiarity with USP/EP, cGMP/EU GMP regulations, and instrument/equipment validation.
• Demonstrated leadership and team management skills.
• Excellent communication, analytical, and problem-solving abilities.
• Strong organizational skills, attention to detail, and the ability to work proactively and independently.

Computer Skills:

• Proficient in MS Office (Outlook, Word, Excel, PowerPoint).

Physical & Travel Requirements:

• Willingness to travel approximately 10%.
• Ability to work on a computer for extended periods.