Global Head of Sterility Assurance and Contamination Control
vor 2 Monaten
Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and dedication of our people, who work together to devise innovative solutions that help businesses improve people's lives. In return, we empower our employees to own their careers, allowing them to make a meaningful impact.
Key Responsibilities:- Develop and implement proactive Sterility Assurance (SA) and microbial contamination control (MCC) programs for Lonza's operations globally.
- Provide strategic and operational leadership for Sterility Assurance/Microbial contamination control across the entire Lonza manufacturing network.
- Drive global SA and MCC strategy, risk assessment, mitigation definition, and gap closure, in close collaboration with all sites and their SA/MCC Leads.
- Assist sites in response 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 a strong relationship with industry peers, relevant industry organizations, and health authorities.
- Bachelor's or Master's 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 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.
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Basel, Basel-Stadt, Schweiz Lonza VollzeitJob SummaryWe 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...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitAbout the RoleWe are seeking a highly experienced and skilled 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...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitGlobal Head of Sterility Assurance and Contamination ControlLonza, a global leader in life sciences, is seeking a highly skilled and experienced professional to lead its Sterility Assurance and Contamination Control efforts globally. As a key member of our team, you will be responsible for developing and implementing proactive Sterility Assurance and...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitGlobal Head of Sterility Assurance and Contamination ControlLonza, a global leader in life sciences, is seeking a highly skilled and experienced professional to lead its Sterility Assurance and Contamination Control efforts globally. As a key member of our team, you will be responsible for developing and implementing proactive Sterility Assurance and...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitJob DescriptionAt Lonza, we are seeking a highly skilled and experienced professional to fill the role of Global Head of Sterility Assurance and Contamination Control. This position is responsible for developing and implementing proactive Sterility Assurance (SA) and microbial contamination control (MCC) programs for Lonza's operations globally.Key...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza, a global leader in life sciences, seeks a highly skilled professional to lead its Sterility Assurance and Microbial Contamination Control initiatives globally. As the Global Head of Sterility Assurance and Contamination Control, you will be responsible for developing and implementing proactive programs to ensure the highest standards of quality and...
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Basel, Basel-Stadt, Schweiz Lonza VollzeitGlobal Head of Sterility Assurance and Microbial Contamination ControlAt Lonza, we are seeking a highly skilled and experienced professional to lead our Sterility Assurance and Microbial Contamination Control (SA/MCC) efforts globally.As the Global Head of SA/MCC, you will be responsible for developing and implementing proactive SA/MCC programs for Lonza's...
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