**General Description:** Perform QC Microbiology environmental monitoring and laboratory activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, BeiGene processes and procedures. As a Senior level analyst, demonstrate proficiency and expertise in environmental monitoring program for the site. **Essential Functions of the job:** + Lead the environmental monitoring program for the site, which includes scheduling of monitoring activities, trending of data, and managing media inventory. + Perform environmental monitoring of cleanroom suites and laboratory areas. + Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time. + Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc. + As required, perform QC Microbiology laboratory testing including bioburden, endotoxin, and sterility to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations. + Manage inventory of reagents and supplies for the laboratory. + Lead appropriate investigation of OOS, discrepancies, error, and failures. + Participate in facility qualification activities for microbiological testing and environmental monitoring. + Participate in internal and external GMP audits where possible. + Train other junior level analysts and new hires. **Core Competencies, Knowledge, and Skill Requirements** + 4+ years’ experience with Bachelor’s or above in Biology, Microbiology, or Biotechnology related scientific discipline, or 6+ years’ experience with less than Bachelors. + Experience in an FDA-regulated biotechnology or pharmaceutical company are required with environmental monitoring experience. + Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, biological indicators, environmental monitoring, etc. + Familiar with the USP/EP and the cGMP/EU GMP. + Familiar with instrument and equipment validation. + Demonstrated leadership/team management skills and experience is a plus. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + 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 BeOne employees. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) + 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.