Terumo Europe
Senior Scientist MSAT(m/w/x)
Vollzeitnur vor OrtSenior
Leverkusen
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Leading technology transfers and scale-up for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience required. Contribution to global healthcare, stability and career opportunities.
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Anforderungen
- Advanced degree (PhD or MS) in Biological Sciences, Engineering or related field
- 3+ years (PhD) or 5+ years (MS) pharmaceutical industry experience
- Over 3 years project leadership experience
- Managing complex cGMP Drug Product manufacturing or development projects
- Deep understanding of Drug Product technologies
- Familiarity with liquid and lyophilized vial filling processes
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Strong experience with validation, risk assessments, and process characterization
- Proven ability to lead complex cross-functional projects
- Involving multiple internal and external stakeholders
- Strong analytical and problem-solving skills
- Data-driven approach to troubleshooting and process improvement
- Excellent communication skills
- Ability to represent MSAT in client interactions, audits, and meetings
- Hands-on, proactive mentality
- Ability to work effectively on shopfloor
- Support real-time troubleshooting
- Ability to transfer knowledge effectively
- Contribute to team development
- Support long-term MSAT strategy building
- Experience with project management tools
- Experience with Minitab
Aufgaben
- Lead technology transfers and scale-up activities
- Support drug product manufacturing processes
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Drive technology transfer from development to manufacturing
- Ensure robust, compliant, and scalable processes
- Develop and execute scale-up strategies
- Conduct risk assessments and process characterization
- Design efficient process validation strategies
- Author and review technical documentation
- Provide scientific support during audits and client interactions
- Troubleshoot manufacturing challenges
- Lead scientific investigations and root cause analysis
- Define CAPA actions
- Contribute to continuous improvement initiatives
- Support new product introductions
- Lead risk assessments
- Define process control strategies
- Prepare process descriptions and instructions
- Create Bills of Materials (BOMs)
- Contribute to technology development
- Serve as technical lead in proposal drafting
- Develop filter validation strategies
- Review related protocols and reports
- Ensure alignment with regulatory and EU GMP Annex 1 requirements
- Demonstrate hands-on engagement
- Share knowledge and build team capabilities
Berufserfahrung
3 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
cGMPMinitab
Benefits
Attraktive Vergütung
- Market-competitive salary
- Market-competitive benefits package
Karriere- und Weiterentwicklung
- Stability and career opportunities
Sinnstiftende Arbeit
- Meaningful impact on global healthcare
- High-responsibility role
Sonstige Vorteile
- Contribution to successful manufacturing
- Support for patients worldwide
- Shaping future technological capabilities
- Ownership of end-to-end technology transfers
- Ownership of process validation
- Influence on sitewide process robustness
- Scientific excellence valued
- Continuous improvement valued
- Client-facing exposure
- Collaboration with Manufacturing
- Collaboration with QA
- Collaboration with Engineering
- Collaboration with external partners
- Representation of MSAT during client interactions
- Representation of MSAT during audits
- Representation of MSAT during project discussions
- Hands-on manufacturing exposure
- Contribution to long-term strategy building
Startup-Atmosphäre
- Ownership of scale-up strategies
- Influence on sitewide process innovation
- Innovative environment
- Data-driven decision making valued
- Collaboration with Development
Abwechslungsreiche Aufgaben
- Cross-functional exposure
- Advanced technology development projects
Weiterbildungsangebote
- Professional growth and development
- Training opportunities
- Development programs
- Capability building valued
- Development of next generation MSAT professionals
Lockere Unternehmenskultur
- Culture of collaboration
- Culture of knowledge sharing
- Openness valued
- Teamwork valued
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Zur Originalanzeige bei Terumo EuropeÜber das Unternehmen
TE
PharmaceuticalsLeverkusen
The company advances lifesaving medical technologies to benefit society and supports healthcare innovation.
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