Director, Sterility Assurance

Lonza Group; Morristown (NJ); On-site; USD 190,000 - 250,000; Full time

Job summary

Lonza Group is seeking a Director, Sterility Assurance to provide global leadership for sterility assurance across its sterile manufacturing network. You will shape strategy, governance, and continuous improvement to ensure world-class contamination control and compliance.

You will lead risk assessments, CAPAs, and cross-site standardization, partnering with development, manufacturing, and regulatory teams to drive quality and operational excellence.

Qualifications

• Significant leadership experience in sterile GMP environments.
• Deep expertise in sterility assurance and microbiology.
• Experience supporting complex investigations and regulatory inspections.

Responsibilities

• Develop and drive global sterility assurance strategy across manufacturing sites.
• Lead risk assessments and CAPA implementation for contamination events.
• Harmonize sterility standards and environmental monitoring programs.
• Support product development, tech transfer, and new facility startups.
• Coach employees on biosafety and aseptic practices; regulatory readiness.

Skills

Leadership

Microbiology

Aseptic processing

Contamination control

Quality risk management

Communication

Stakeholder management

Global alignment

Education

Bachelor's degree in Microbiology or related

Master's degree or higher advantageous

Job description

Today, Lonza is a global leader in life sciences, operating across five continents, Lonza works every day to enable a healthier world. Our greatest scientific solution is talented people working together, devising ideas that help businesses improve lives. In exchange, we empower our employees to own their careers and genuinely make a meaningful difference.

We are seeking an experienced Director, Sterility Assurance to provide global leadership for sterility assurance and contamination control across Lonza's sterile manufacturing network. This highly visible role will drive enterprise-wide strategy, governance, and continuous improvement initiatives to ensure world-class biological contamination control and compliance across sterile drug substance and drug product operations.

Key Responsibilities

Global Sterility Assurance Leadership

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.

Risk Management and Site Support

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.

Network Standardization and Continuous Improvement

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.

New Product Introduction and Technical Expertise

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.

Capability Building and Regulatory Support

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.

What You'll Bring

Education

Bachelor's, Master's, or higher degree in Microbiology, Pharmaceutical Sciences, Life Sciences, Biotechnology, Engineering, or a related scientific discipline.

Advanced scientific qualifications or certifications are advantageous.

Experience

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.

Skills

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.

Every Day, Lonza's Products and Services Have a Positive Impact

At Lonza, you will join a purpose-driven organization where your expertise contributes directly to the development and manufacture of therapies that improve and save lives worldwide. We foster a culture of innovation, collaboration, and continuous learning, providing opportunities to make a meaningful impact on a global scale.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a privilege, but a responsibility we take seriously.