QC Microbiology Sr. Analyst

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:

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

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: $89,100.00 - $124,100.00 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.