Director, Global Microbiology Governance – Oversight

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $168k - $228k / year

⏰ Full Time

🔴 Lead

🎲 Risk

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Provide global strategic leadership and governance for contamination control strategy across manufacturing sites • Establish standards and ensure consistent implementation and regulatory compliance • Ensure operations 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 for microbial limits, sterility, endotoxin, and bioburden testing • Drive harmonization of microbiological practices across the global network • Provide technical leadership for complex or high-risk microbial investigations, including OOS results, Environmental Monitoring excursions, and contamination events • Lead root-cause analysis and implement effective 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, capital projects, and product introductions • Partner with Manufacturing, R&D, and Engineering to assess microbiological risks during process changes and facility modifications • Lead new technology implementation and Operational Excellence projects • Provide leadership through global influence, governance, and expertise

🎯 Requirements

• 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 • Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS • Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS) • Strong analytical troubleshooting skills • Rigorous attention to detail • Excellent technical writing skills for regulatory submissions and investigation reports • Knowledge of FDA, EMA, cGMP, and USP/EP compendial standards • Up to 20% travel

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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