Associate Director, QC Microbiology

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 BeOne 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 BeOne 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.

Other Qualifications:

• Minimum of 8 years relevant working experience in an FDA-regulated biotechnology or pharmaceutical company.

• Minimum of 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.

Education:

• Bachelor's Degree in Science (ideally microbiology, pharmaceutical sciences, biotechnology or related).

Computer Skills:

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

Travel:

• Must be willing to travel approximately 10%

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

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.