Senior Director Global Head Sterility Assurance and Microbial Contamination Control

vor 1 Monat


Basel, Basel-Stadt, Schweiz Lonza Vollzeit

Global Sterility Assurance and Microbial Contamination Control Leader

Lonza, a global leader in life sciences, is seeking a highly skilled and experienced professional to fill the position of Global Head Sterility Assurance and Microbial Contamination Control. This role is responsible for developing and implementing proactive Sterility Assurance (SA) and microbial contamination control (MCC) programs for Lonza's operations globally.

Key Responsibilities:

  • Provides strategic and operational leadership for Sterility Assurance/Microbial contamination control across the entire Lonza manufacturing network.
  • Drives and oversees global SA and MCC strategy, risk assessment, mitigation definition, and gap closure.
  • Responsible for assisting sites in response to adverse trends or contamination events with root cause analysis and global implementation of preventive actions.
  • Develops, implements, and continuously improves biological 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.

Requirements:

  • Bachelor's or Master's in a relevant field, 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.


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