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Associate Director, Aseptic Production (m/f/d)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Here are the key dimensions of your role in the Finished Products department:
Manage the Finished Products department (4 direct reports, about 35 reports in the organization)
- Responsible for establishing the recruitment plan
- Perform the function as Project Team Member in projects of strategic importance
Provide expertise regarding aseptic filling best practices
- Ensure knowledge of pharmaceutical production, up to date and in accordance with best practices in the pharmaceutical industry.
- Provide expertise to industry best practices for technical project management.
EHS Safety and security of production areas
- A reliable and constant production of quality products
- Continuous preparation for regulatory inspections in compliance with GMP, Merck rules and site SOPs while delivering complete and precise documentation
- Establishment of the department's CAPEX budget and correct management of OPEX within the agreed financial limits, providing regular forecasts
- Compliance with the rules governing the progress of projects (URS, CdC, qualification and technical documents for installations) - Autonomous management of minor changes in accordance with GMP
- Prepare the department for regulatory inspections (health and legal authorities)
- Ensure production staff receive appropriate training to work safely and efficiently in accordance with GMP
- Establish and maintain production planning to ensure a supply of products in accordance with requirements and provide data for reports
- Minimize process variability by analyzing trends and taking appropriate corrective actions
- Continuously search for potential improvements in terms of performance, efficiency, and robustness, and implement them in accordance with QA and RA requirements and in coordination with the other sites involved.
Documentation, conformity and process
- Ensure all documentation associated with the manufacture of products is authorized by the QA and it’s implemented in the department
- Check the presence of all the documentation necessary for the qualification (VP, DQ, IQ, OQ, PQ) and for the operation of the equipment.
- Ensure an efficient transfer of projects to the Finished Products department.
Who you are
- Considerable experience in aseptic operations on a biotech manufacturing site
- Demonstrated experience in a GMP environment and leading role during audits
- Proven leadership capabilities to lead and inspire a large-sized organization
- Ability to think strategically while keeping a strong focus on operational performance
- Fluency in French and English
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!