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.
The Director, Global Microbiology Governance & Oversight ensures the safety, purity, and efficacy of biopharmaceutical products. This role oversees contamination control strategies, environmental monitoring programs, and microbial identification systems across manufacturing facilities. The Director will align laboratory operations with global regulatory standards to ensure continuous compliance and product safety.
Essential Functions of the Job:
Provide global strategic leadership and governance for contamination control strategy across manufacturing sites, establishing standards and ensuring consistent implementation and regulatory compliance.
Ensure all operations strictly adhere to FDA, EMA, cGMP, and USP/EP compendial standards; act as a subject matter expert during regulatory inspections and audits.
Establish and maintain global microbiology standards and governance related to microbial limits testing, sterility testing, endotoxin testing, and bioburden assays for raw materials, in-process samples, and final drug products across manufacturing sites.
Drive harmonization of microbiological practices across the global network.
Provide technical leadership for complex or high-risk microbial investigations across sites, such as out-of-Specification (OOS) results, Environmental Monitoring excursions, and contamination events. Lead root-cause analysis and implement effective Corrective and Preventive Actions (CAPA).
Identify emerging microbiological and regulatory risks and translate them into global Quality standards.
Build and lead a global microbiology community of practice or technical network.
Provide strategic microbiology input to new facilities, technology transfers, major capital projects, and/or product introductions.
Partner with Manufacturing, R&D, and Engineering to assess microbiological risks using appropriate risk-management methodologies during process changes and facility modifications.
Lead new technology implementation and Operation Excellence (OE) projects.
Supervisory Responsibilities:
Leadership through global influence, governance, expertise.
Computer Skills:
Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS.
Other Qualifications:
Technical Expertise: Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS).
Core Competencies: Strong analytical troubleshooting skills, rigorous attention to detail, and excellent technical writing skills for regulatory submissions and investigation reports.
Travel:
Up to 20%
Education:
Bachelor’s degree and 10+ years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment required
Master’s degree and 7+ years of Biopharmaceutical experience preferred
Doctoral Degree and 5+ years of Biopharmaceutical experience
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: $168,000.00 - $228,000.00 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,…