Terumo Europe
.MSAT Senior Scientist(m/w/x)
Vollzeitnur vor OrtSenior
Leverkusen
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Leading technology transfers and process optimization for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience required. Shaping future technological capabilities, high-responsibility role.
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Anforderungen
- Advanced degree (PhD or MS) in Biological Sciences, Engineering or related field
- 3+ years pharmaceutical industry experience (PhD)
- 5+ years pharmaceutical industry experience (MS)
- Over 3 years project leadership experience
- Managing complex cGMP Drug Product manufacturing/development projects
- Deep understanding of Drug Product technologies
- Familiarity with PFS, liquid and lyophilized vial filling
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Knowledge of EU GMP Annex 1
- Strong experience with validation, risk assessments, 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, cross-functional 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
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Develop and optimize drug product manufacturing processes
- 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 and implement CAPA actions
- Support new product introductions
- Lead risk assessments and 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 regulatory and EU GMP Annex 1 compliance
- Engage hands-on in tech transfer and manufacturing
- Share knowledge and build team capabilities
Berufserfahrung
3 Jahre
Ausbildung
Doktor / Ph.D.
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
Minitab
Benefits
Attraktive Vergütung
- Market-competitive salary and benefits package
Karriere- und Weiterentwicklung
- Stability and career opportunities
- Develop next generation of MSAT professionals
Sinnstiftende Arbeit
- Contribution to successful manufacturing of high-quality drug products
- High-responsibility role
Sonstige Vorteile
- Shaping future technological capabilities
- Ownership of end-to-end technology transfers
- Process validation
- Scientific excellence
- Data-driven decision making
- Continuous improvement
- Represent MSAT during client interactions, audits, and project discussions
- Hands-on manufacturing exposure
- Contribution to long-term strategy building
Startup-Atmosphäre
- Scale-up strategies
- Influence on sitewide process robustness and innovation
- Innovative environment
- Collaboration with Manufacturing, QA, Engineering, Development, and external partners
Abwechslungsreiche Aufgaben
- Cross-functional and client-facing exposure
- Advanced technology development projects
Weiterbildungsangebote
- Professional growth and development
- Training opportunities
- Development programs
Lockere Unternehmenskultur
- Culture of collaboration and knowledge sharing
- Openness, teamwork, and capability building
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TE
PharmaceuticalsLeverkusen
The company advances lifesaving medical technologies to benefit society and supports healthcare innovation.
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