Senior Director, Global Head MCC & Sterility Assurance

at  Lonza

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are looking for a Global Head, MCC & Sterility Assurance (f/m/d), who will be responsible for developing and implementing proactive Sterility Assurance (SA) and microbial contamination control (MCC) programs for Lonza’s operations globally.
Join us today and apply for this exciting opportunity at Lonza.

Key responsibilities:

• Provides strategic and operational leadership and management for Sterility Assurance/Microbial contamination control across the entire Lonza manufacturing network (cross-divisional: Biologics, Cell & Gene Therapy, etc.)
• Drives and oversees global SA and MCC strategy, risk assessment, mitigation definition and gap closure, as well as sustainable implementation in close collaboration with all sites and their SA / MCC Leads
• Responsible to assist sites in response to adverse trends or contamination events with root cause analysis and global implementation of preventive actions where appropriate
• Drives and oversees global SA and MCC strategy in close collaboration with the Global Head of Sterility Assurance & MCC of the other divisions
• For Biologics division, drives and oversees global SA and MCC strategy in close collaboration with all sites and their SA / MCC Leads
• Develops, implements and continuously improves the biological (viral, bacterial, fungal, mycoplasma, and other adventitious agents) contamination control strategies for low bioburden Drug Substance, intermediates and sterile drug product manufacturing
• Supports coaching and training of employees at manufacturing sites to improve understanding of biological risks and aseptic practices
• Improves standardized procedures across the network for microbiological and segregation control aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning / disinfection
• Responsible Global expert for implementing phase-appropriate SA / MCC practices as part of the new product introduction process and through interactions with project teams and customers
• Accountable for developing/maintaining a compliant and effective industry-standard SA and MCC strategy across the Lonza network (all Divisions)
• Develops, implements and continuously improves useful and executable SA / MCC standards and procedures taking customer processes and Lonza requirements into consideration, in line with current regulations and industry standards
• Tracks related Key Performance Indicators and owns the response to improve performance.
• Sets global direction for SA / MCC and leads implementation through site sterility assurance teams
• Owns and improves standard responses to contamination events and ensures preventive actions are globally implemented (as appropriate) to reduce the risk of re-occurrence of events across the Lonza network
• Establishes and implements a standard approach for end-to-end risk assessments and risk mitigations for existing processes, or as part of tech transfers and new facility / process unit designs regarding contamination prevention
• Establishes a platform for best practice sharing and process standardization across sites in the network and enables industry best-in-class offerings for our customers in this field
• Ensures a culture of mutual accountability and full collaboration with the customer and Lonza sites as well as departments for effective contamination control
• Forges strong relationships with other departments (e.g., Manufacturing, Quality Control, Analytical Services, Engineering, Process Development) and other Lonza Divisions to foster a process of continual improvement and information sharing
• Establishes and leads a lean and efficient SA / MCC governance program at Lonza to enable early discovery of potential issues and their timely resolution
• Establishes a strong relationship with industry peers, relevant industry organizations such as ISPE/PDA and health authorities

Key requirements:

• Bachelor’s or Master`s in relevant field, Microbiology, Biology or Pharmacy
• Excellent working knowledge of cGMP and the regulatory requirements for manufacture of sterile and low Bioburden products (FDA, EMA, PIC/s)
• Experience within aseptic / sterile manufacturing and Quality Assurance in the pharmaceutical industry
• Proven hands-on experience in sterility assurance and contamination control and troubleshooting
• Ability to apply microbiological control concepts and risk assessment in a practical way, and to coach / teach team members in these areas
• Hands-on experience in complex investigations in both preventive and reactive contamination control
• Knowledge and experience in microbiological test technologies/methodology
• Technical knowledge of aseptic facility design, clean room engineering, including particle and microbial control mechanisms, qualification and maintenance of clean rooms
• Working knowledge of requirements and strategy for aseptic process simulations / media fills
• Working knowledge and experience in developing training programs for aseptic and low bioburden operations
• Working knowledge of environmental monitoring requirements for aseptic / sterile operations

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference

• Provides strategic and operational leadership and management for Sterility Assurance/Microbial contamination control across the entire Lonza manufacturing network (cross-divisional: Biologics, Cell & Gene Therapy, etc.)
• Drives and oversees global SA and MCC strategy, risk assessment, mitigation definition and gap closure, as well as sustainable implementation in close collaboration with all sites and their SA / MCC Leads
• Responsible to assist sites in response to adverse trends or contamination events with root cause analysis and global implementation of preventive actions where appropriate
• Drives and oversees global SA and MCC strategy in close collaboration with the Global Head of Sterility Assurance & MCC of the other divisions
• For Biologics division, drives and oversees global SA and MCC strategy in close collaboration with all sites and their SA / MCC Leads
• Develops, implements and continuously improves the biological (viral, bacterial, fungal, mycoplasma, and other adventitious agents) contamination control strategies for low bioburden Drug Substance, intermediates and sterile drug product manufacturing
• Supports coaching and training of employees at manufacturing sites to improve understanding of biological risks and aseptic practices
• Improves standardized procedures across the network for microbiological and segregation control aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning / disinfection
• Responsible Global expert for implementing phase-appropriate SA / MCC practices as part of the new product introduction process and through interactions with project teams and customers
• Accountable for developing/maintaining a compliant and effective industry-standard SA and MCC strategy across the Lonza network (all Divisions)
• Develops, implements and continuously improves useful and executable SA / MCC standards and procedures taking customer processes and Lonza requirements into consideration, in line with current regulations and industry standards
• Tracks related Key Performance Indicators and owns the response to improve performance.
• Sets global direction for SA / MCC and leads implementation through site sterility assurance teams
• Owns and improves standard responses to contamination events and ensures preventive actions are globally implemented (as appropriate) to reduce the risk of re-occurrence of events across the Lonza network
• Establishes and implements a standard approach for end-to-end risk assessments and risk mitigations for existing processes, or as part of tech transfers and new facility / process unit designs regarding contamination prevention
• Establishes a platform for best practice sharing and process standardization across sites in the network and enables industry best-in-class offerings for our customers in this field
• Ensures a culture of mutual accountability and full collaboration with the customer and Lonza sites as well as departments for effective contamination control
• Forges strong relationships with other departments (e.g., Manufacturing, Quality Control, Analytical Services, Engineering, Process Development) and other Lonza Divisions to foster a process of continual improvement and information sharing
• Establishes and leads a lean and efficient SA / MCC governance program at Lonza to enable early discovery of potential issues and their timely resolution
• Establishes a strong relationship with industry peers, relevant industry organizations such as ISPE/PDA and health authoritie