General Description:

Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling programs for WFI, Clean Steam, and Process Gases in accordance with FDA/EU regulations, applicable International Regulations, and BeOne processes and procedures. Oversees and implements QC Microbiology procedures. Authors and reviews QC Microbiology Deviations and Trend Reports. Supports commissioning and qualification of new laboratory equipment. Supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.

Essential Functions of the job:

• Lead the Environmental Monitoring (EM) and Utilities Sampling programs in accordance with FDA/EU regulations and applicable International Regulations.
• Compile, author and review QC Trend Reports for Environmental and Utilities Monitoring.
• Build a highly efficient QC microbiology team, identify and develop key talents.
• Oversee gowning and aseptic qualifications for site wide personnel.
• Author and review QC Microbiology Deviations, CAPAs and Change Controls.
• Lead QC Microbiology laboratory activities to support GMP manufacturing and microbiological testing of materials, intermediates, and finished products in accordance with FDA/EU regulations.
• Manage QC Micro-Lab routine operations, including but not limited to microbiological sampling, testing, data review, personnel training, and equipment maintenance.
• Ensure Micro-Lab EHS compliance.
• Ensure timely completion of sampling (EM, WFI, Clean Steam, and Process Gases) to support QC testing as well as 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.
• Participate 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.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.
• Interacts with all levels of BeOne employees.

Required Education / Experience:

• Bachelor's Degree or above in Microbiology or Biotechnology related scientific discipline. Scientific degree (ideally microbiology, pharmaceutical sciences, biotechnology or related).
• Minimum of 7 years' experience in biological drug product Quality Control in a FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
• Minimum of 5 years' experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation
• Expert in environmental monitoring, utilities sampling, pharmaceutical microbial testing and related equipment/instruments.
• Familiar with the 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.

Supervisory Responsibilities:

• Manage direct reports from QC Micro-Lab.

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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $127,400.00 - $172,400.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.