Analyst, QC Microbiology – Product Testing

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:

Performs 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. Perform QC Microbiology utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases as well as environmental monitoring of cleanroom suites and laboratory areas.

Essential Functions of the job:

• Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.

• Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.

• Perform environmental monitoring of cleanroom suites and laboratory areas as required.

• Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.

• Manage inventory of reagents and supplies for the laboratory.

• Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.

• Implement corrective actions and preventive actions (CAPAs).

• Participate in facility qualification activities for microbiological testing and environmental monitoring.

• Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.

• Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.

• Undertake any other duties as required.

Education and Experience Required:

• Bachelor’s Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.

• Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.

• 5+ years of experience preferred with no higher education.

• Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.

• Familiar with USP/EP and cGMP/EU GMP regulations.

• Familiar with instrument and equipment validation.

• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

• 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 Contracts:

• Interacts with all levels of BeiGene employees.

Supervisory Responsibilities:

• NA

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: $79,000.00 - $109,000.00 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 t