Director, Sterility Assurance

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🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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Lonza

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🧬 Biotechnology

💊 Pharmaceuticals

🏭 Manufacturing

💰 $444.8M Post-IPO Debt - Lonza on 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza is a Swiss-based, global contract development and manufacturing organization (CDMO) and life sciences company. It provides integrated end-to-end offerings across biologics and small-molecule drug development and manufacturing — including cell line development, process and analytical development, formulation and primary packaging, drug substance and drug product manufacturing, and regulatory/CMC support. Lonza's capabilities span advanced synthesis and APIs (including HPAPIs), bioconjugation and ADCs, specialized modalities such as cell & gene therapies, mRNA/LNP, microbial processes, and capsule and health-ingredient products. Founded in Switzerland in 1897, Lonza describes itself as a pioneer and world leader in the CDMO industry and operates with ~20,000 colleagues across five continents to support pharmaceutical and biotech customers.

📋 Description

• Develop, implement, and continuously improve biological contamination control strategies addressing viral, bacterial, fungal, mycoplasma, endotoxin, and other adventitious agent risks • Drive and oversee the global sterility assurance strategy, including risk assessment, mitigation planning, gap closure, and sustainable implementation across manufacturing sites • Serve as a global subject matter expert and strategic leader for contamination control and aseptic manufacturing practices • Lead global sterility assurance risk assessments and support sites in responding to contamination events, sterility failures, microbiological excursions, and adverse trends • Facilitate root cause investigations and implement effective corrective and preventive actions (CAPAs) across the network • Promote cross-site collaboration, knowledge sharing, and implementation of best practices • Drive harmonization of sterility assurance standards and contamination control programs across global sites • Establish and improve procedures governing facility and equipment design, process design, material transfer, environmental monitoring, microbiological testing, maintenance, cleaning, disinfection, and segregation controls • Champion continuous improvement initiatives that strengthen contamination control, consistency, and inspection readiness • Act as the global sterility assurance expert for product development, technology transfer, and new product introductions • Ensure phase-appropriate sterility assurance practices are embedded throughout development and commercial manufacturing programs • Support network expansion projects and new facility start-ups as required • Coach and train employees to strengthen understanding of biological risks, contamination control, and aseptic behaviors • Support regulatory inspections, customer audits, GQC audits, mock pre-approval inspections, due diligence activities, and other compliance initiatives as a sterility assurance SME • Monitor evolving industry and regulatory expectations and ensure timely implementation across the network

🎯 Requirements

• Bachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline • Significant leadership experience within sterile pharmaceutical, biotechnology, biologics, cell and gene therapy, or related GMP-regulated environments • Deep expertise in sterility assurance, contamination control, microbiology, aseptic processing, and quality risk management • Demonstrated experience supporting complex investigations, contamination events, and regulatory inspections • Proven success influencing and leading within global, matrixed organizations • Expert knowledge of sterile manufacturing regulations and industry standards • Strong understanding of contamination control strategies and microbiological risk assessment • Excellent communication, coaching, and stakeholder management skills • Ability to drive global alignment while balancing site-specific operational needs • Continuous improvement mindset with a passion for scientific excellence and operational effectiveness

🏖️ Benefits

• Purpose-driven organization contributing to therapies that improve and save lives worldwide • Opportunities to make a meaningful impact on a global scale • Culture of innovation, collaboration, and continuous learning • Opportunities for career ownership and meaningful difference