Shape the Future of Sterile Manufacturing Through Science, Technology and Leadership

For our Animal Health organization, we are currently recruiting a Regional Lead Aseptic Process Solutions (Europe & Asia Pacific)

This position can be based in Boxmeer (NL), Unterschleissheim (D) or Krems (A).

Welcome to our team

Our Global Science and Technology division provides technical leadership to our Animal Health manufacturing network, using science, technology and innovation to enable successful new product launches and ensure reliable supply of our existing portfolio. Within this division, our global Aseptic Process Solutions team includes around 30 specialists across 9 countries and 4 continents. The team provides deep technical support to production and quality organization's worldwide, ensuring robust processes and the consistent supply of our sterile products. Our mission is to lead Aseptic Excellence across our internal and external sterile network. We deliver this through fit for purpose standards, a zero sterile reject mindset, strong microbiology capability and a culture of continuous improvement. To strengthen our organization and to lead a regional team of 10 APS specialists, we are seeking a Regional Lead APS covering Europe and the Asia Pacific region.

Purpose of the role

Reporting to the Global APS Lead, this important new role drives excellence, innovation and continuous improvement across aseptic operations in Europe and the Asia Pacific region. You will provide strategic microbiology and aseptic leadership to the regional APS team and guide improvements across the sterile manufacturing network. You will initiate and lead a broad range of improvement projects that strengthen aseptic practice, contamination control, regulatory compliance, team capability and data driven risk management. You will also play a key role in supporting capital engineering projects across the region, ensuring new and existing assets meet the highest technical and compliance expectations to enable right first time manufacturing. Close collaboration with leaders in Manufacturing, Quality, Engineering and Science and Technology at local, regional and global levels will be essential.

Tasks and responsibilities are, but not limited to

Lead, coach and develop the regional APS team, building technical, microbiological and leadership capability.
Contribute to the deployment of the APS and S&T Excellence strategy across Europe and the Asia Pacific region.
Define, implement and continuously improve aseptic practices, policies and procedures in partnership with Operations, Engineering, Quality, Research and Development and other S&T functions.
Drive operational excellence through process optimization, automation, best practice deployment, and right first-time technology transfer and asset introduction.
Provide expert microbiology and contamination control support to sterile and non-sterile sites across the internal and external network.
Lead investigations and root cause analyses for contamination deviations and ensure effective corrective and preventive actions.
Serve as the Global Owner of Animal Health Sterile Standards, providing microbiology and contamination control leadership under the AH Quality Management System.
Lead a global team of aseptic and microbiology experts to set strategy, maintain AHQM content, and ensure consistent implementation through governance, training and Communities of Practice.
Develop and maintain systems, processes and metrics to monitor aseptic performance, including a network aseptic risk heatmap.
Ensure alignment with global and local regulatory requirements and translate new expectations into practical guidance for the network.
Stay current with relevant regulations, guidelines, and industry standards.
Build strong cross functional and cross-regional relationships, including close partnership with Human Health colleagues to share learnings and align best practices.

Your profile

Bachelor or Master degree in Pharmaceutical Sciences, Biotechnology, Process Engineering, Microbiology or a related field.
At least 15 years of industry experience in sterile manufacturing with increasing levels of responsibility and leadership.
Deep knowledge of antigen and aseptic processes, including fermentation, cell culture, purification, sterilization technologies, compounding and sterile filling.
Strong understanding of pharmaceutical microbiology, biotechnology, equipment and cleanroom design, environmental monitoring and aseptic techniques.
Solid experience with regulatory expectations including FDA, USDA, EMA Annex 1 and other relevant international guidelin