Global Head of Sterility Assurance and Contamination Control

vor 4 Wochen

Basel, Basel-Stadt, Schweiz Lonza Vollzeit
Job Summary

We are seeking a highly skilled and experienced professional to lead our Sterility Assurance and Contamination Control efforts globally. As the Global Head of Sterility Assurance and Contamination Control, you will be responsible for developing and implementing proactive Sterility Assurance and microbial contamination control programs for our operations worldwide.

Key Responsibilities
  • Provide strategic and operational leadership for Sterility Assurance and Microbial Contamination Control across our global manufacturing network.
  • Develop and oversee global Sterility Assurance and Contamination Control strategy, risk assessment, mitigation definition, and gap closure.
  • Collaborate with sites and their Sterility Assurance/Contamination Control Leads to implement sustainable Sterility Assurance and Contamination Control practices.
  • Assist sites in responding to adverse trends or contamination events with root cause analysis and global implementation of preventive actions.
  • Develop, implement, and continuously improve biological contamination control strategies for low bioburden Drug Substance, intermediates, and sterile drug product manufacturing.
  • Support coaching and training of employees at manufacturing sites to improve understanding of biological risks and aseptic practices.
  • Improve 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.
  • Establish and maintain a compliant and effective industry-standard Sterility Assurance and Contamination Control strategy across the Lonza network.
Requirements
  • Bachelor's or Master's degree in a relevant field, such as Microbiology, Biology, or Pharmacy.
  • Excellent working knowledge of cGMP and 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 coach/teach team members in these areas.
About Lonza

At Lonza, we are committed to improving lives through innovative solutions in life sciences. We respect and protect our people and our environment, and we strive to achieve our business results in an ethical and responsible manner.

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