Director, Global Microbiology Governance & Oversight

BeOne Medicines USA; United States; Vor Ort; USD 168.000 - 228.000; Vollzeit

Benefits dieser Stelle

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Zusammenfassung

BeOne Medicines USA is seeking a senior microbiology leader to provide global governance of contamination control strategies across manufacturing sites. The role ensures strict adherence to regulatory standards and supports audits and inspections.

You will establish global microbiology standards for microbial testing and lead investigations and CAPA with cross-functional teams. The ideal candidate has advanced degrees with extensive cGMP biopharmaceutical experience, strong regulatory writing

Qualifikationen

• Bachelor's degree in microbiology or related field with 10+ years of cGMP biopharmaceutical experience.
• Master's degree in Biopharmaceuticals preferred with 7+ years experience.
• Doctoral degree in Biopharmaceuticals with 5+ years of experience.

Aufgaben

• Provide global strategic leadership and governance for contamination control strategy across manufacturing sites.
• Ensure operations comply with FDA, EMA, cGMP, and USP/EP; support regulatory inspections and audits.
• Establish and maintain global microbiology standards for microbial limits testing, sterility, endotoxin, and bioburden.
• Drive harmonization of microbiological practices across the global network.
• Lead complex microbial investigations and CAPA across sites.

Kenntnisse

Aseptic processing

Cleanroom qualification

Environmental monitoring

LIMS proficiency

Regulatory writing

Ausbildung

Bachelor's degree in microbiology

Master's degree in Biopharmaceuticals

Doctoral Degree in Biopharmaceuticals

Tools

LIMS

Microsoft 365

Jobbeschreibung

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.

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

• 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, 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. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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

We are proud to be an equal opportunity employer.

BeOne does not discriminate on the basis of race, religion, colo