What are the responsibilities and job description for the Manager QC Microbiology, US site (Hopewell, NJ) position at BeiGene?
General Description :
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. Oversees and implements QC Microbiology procedures. Authors and reviews QC Microbiology Deviations and Trend Reports. Supports commissioning and qualification of a new manufacturing facility. Supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.
Essential Functions of the job :
Author and review QC Microbiology Deviations and Trend Reports.
Lead QC Microbiology laboratory activities to support GMP manufacturing and microbiological testing of materials, intermediates, and finished products in accordance with FDA / EU regulations.
Lead an environmental monitoring (EM) program in accordance with FDA / EU regulations and applicable International Regulations.
Build a high efficient QC microbiology team, identify and develop key talents.
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.
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.
Core Competencies, Knowledge and Skill Requirements
Scientific degree (ideally microbiology, pharmaceutical sciences, biotechnology or related).
Minimum of 5 years working experience and 2 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.
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.
Significant Contacts
- Interacts with all levels of BeiGene employees.
Education Required :
Bachelor’s Degree or above in Microbiology or Biotechnology related scientific discipline.
Supervisory Responsibilities :
Computer Skills :
Other Qualifications :
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.
