Manager QC Microbiology, US site (Hopewell, NJ)

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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

• Manage direct reports from QC Micro-Lab.
  
  

Computer Skills

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

Other Qualifications

• None
  
  

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: $108,100.00 - $148,100.00 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 BeiGene, 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.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.