General Description:

Leads and manages all QC Microbiology laboratory activities to support GMP manufacturing, including Environmental Monitoring (EM) and microbiological testing of materials, intermediates, and finished products in accordance with FDA/EU regulations, applicable International Regulations, and BeiGene processes and procedures. Establishes a new QC Microbiology laboratory and implements QC Microbiology procedures. Supports commissioning and qualification of a new manufacturing facility. Participates in regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.

Essential Functions of the job :

• Lead the new QC Microbiology laboratory (Micro-Lab) set up, including commissioning/qualification of cleanrooms and equipment.

• Establish an environmental monitoring (EM) program in accordance with FDA/EU regulations and applicable International Regulations.

• Support critical utility qualification, including water for injection (WFI), clean steam, and process gases.

• Lead the Environmental Monitoring Performance Qualification (EMPQ) of cleanrooms.

• Establish QC microbiology laboratory procedures and test methods in accordance with health authority regulations and BeiGene Global quality standards.

• Manage QC Micro-Lab routine operations, including but not limited to microbiological testing, data review, personnel training, and equipment maintenance.

• Lead the establishment of a cross contamination strategy for the manufacturing site.

• Ensure Micro-Lab EHS compliance.

• Ensure timely completion of testing (DS, DP release and stability testing, raw materials testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

• Ensure appropriate investigation of OOS events and Microbial Data Deviations (MDD).

• Ensure appropriate corrective actions and preventive actions (CAPAs) are implemented to prevent recurrence of OOS and MDDs.

• Significant participation in internal and external GMP audits.

• Manage microbial method verification activities, including the verification strategy and approval of protocols and reports.

• Ensure that the QC Micro-Lab meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.

• Introduce advanced concept of microbiology laboratory to keep the laboratory forward-looking and competitive in the industry.

• Build a highly efficient QC microbiology team. Identify and develop key talents by mentoring, motivating, coaching direct reports to higher levels of capability.

• Undertake any other duties as required.

Core Competencies, Knowledge and Skill Requirements

• Scientific degree (ideally microbiology, pharmaceutical sciences, biotechnology or related).

• Minimum of 7 years working experience and 5 years team management experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.

• Expert with pharmaceutical microbial testing and related equipment/instruments.

• Knowledgeable with USP/EP and cGMP/EU GMP regulations.

• Experience with microbial contamination control of aseptic process.

• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

• Wide knowledge of analytical methods and electronic systems (LIMS, MODA) used in the QC Micro-Lab.

• Strong leadership/team management skills and experience.

• Credible and confident communicator (written and verbal) at all levels.

• Strong analytical and problem-solving ability.

• Excellent project management skills.

• Hands-on approach, with a ‘can do’ attitude.

• Ability to prioritize, demonstrating good time management skills.

• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

• Self-motivated, with the ability to work proactively using own initiative.

• Committed to learning and development.

Significant Contacts

• Interacts with all levels of BeiGene employees

Supervisory Responsibilities:

• Manage direct reports from QC Micro-Lab.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

• Ability to work on a computer for extended periods of time

Travel:

• Must be willing to travel approximately 10%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.