Associate Director, QC Microbiology

BeiGene, Ltd.; Hopewell (VA); On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines Ltd. seeks aSenior QC Microbiology Laboratory Lead to manage the new Micro-Lab setup and environmental monitoring program. You will oversee microbiological testing of materials, intermediates, and finished products under GMP, ensuring compliance with FDA/EU requirements.

You will lead a team, drive lab QA processes, and manage CAPAs, investigations, and audits to uphold quality and regulatory standards across the manufacturing site.

Qualifications

• Bachelor's degree in science; ideally microbiology, pharmaceutical sciences or related.
• Experience with FDA/EU GMP regulations and quality systems.
• Strong knowledge of microbial testing and related equipment.
• Familiarity with USP/EP guidelines and EC/EU GMP requirements.
• Proven leadership and project management in a regulated lab setting.

Responsibilities

• Lead and establish the new QC Microbiology lab, including commissioning/qualification of cleanrooms and equipment.
• Establish an environmental monitoring program in line with FDA/EU regulations.
• Provide oversight of EM testing, PEC and WFI process utilities.
• Manage day-to-day QC Micro-Lab operations and data review.
• Ensure timely testing, release, stability and reporting for manufacturing.
• Drive CAPAs and investigations of OOS/MDD events.
• Prepare for and participate in GMP audits.

Skills

Leadership

Project management

Regulatory knowledge

Quality systems

Analytical thinking

Education

Bachelor's Degree in Science (microbiology or related)

Tools

LIMS

MODA

Job description

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

Leads and 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 BeOne processes and procedures. Establishes a new QC Microbiology laboratory and implements QC Microbiology procedures. Supports commissioning and qualification of a new manufacturing facility. Participates in regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Microbiology laboratory.

Essential Functions of the job

• Lead the new QC Microbiology laboratory (Micro-Lab) set up, including commissioning/qualification of cleanrooms and equipment.
• Establish an environmental monitoring (EM) program in accordance with FDA/EU regulations and applicable International Regulations.
• Support critical utility qualification, including water for injection (WFI), clean steam, and process gases.
• Lead the Environmental Monitoring Performance Qualification (EMPQ) of cleanrooms.
• Establish QC microbiology laboratory procedures and test methods in accordance with health authority regulations and BeOne Global quality standards.
• 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.
• Significant participation 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.
• Build a highly efficient QC microbiology team.
• Identify and develop key talents by mentoring, motivating, coaching direct reports to higher levels of capability.
• Undertake any other duties as required.

Other Qualifications

• Minimum of 8 years relevant working experience in an FDA-regulated biotechnology or pharmaceutical company.
• Minimum of 5 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.
• Knowledgeable with 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.

Education

Bachelor's Degree in Science (ideally microbiology, pharmaceutical sciences, biotechnology or related).

Computer Skills

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

Travel

Must be willing to travel approximately 10%.

Global Competencies

• 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

$133,800.00 - $183,800.00 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 BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

BeOne is proud to be an equal opportunity employer. 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.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

For more information, please visit the link to explore job opportunities in China Mainland.

China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit