Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Vollzeitnur vor OrtManagement
Köln
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
TETerumo Europe
MSAT Senior Scientist(m/w/x)
Leverkusen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading technology transfers and process validation for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience managing complex cGMP drug product projects required. High-responsibility role in an innovative environment.
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 or development projects
- Deep understanding of Drug Product technologies
- Familiarity with PFS, liquid and lyophilized vial filling
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Strong experience with 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, 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 is an asset
- Experience with Minitab is an asset
Aufgaben
- Lead technology transfers and scale-up activities
- Support process validation for drug product manufacturing
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Act as subject matter expert for drug product technologies
- Contribute to process and technology development
- Support operational excellence across the site
- 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 and contribute to continuous improvement
- Support new product introductions
- Lead risk assessments and define process control strategy
- 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 during tech transfer
- Share knowledge and build team capabilities
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP Drug Product manufacturing
- Drug Product technologies
- PFS
- liquid and lyophilized vial filling
- EU GMP Annex 1
- validation
- risk assessments
- process characterization
- project management tools
- Minitab
Benefits
Attraktive Vergütung
- Market-competitive salary and benefits package
Karriere- und Weiterentwicklung
- Stability and career opportunities
Sinnstiftende Arbeit
- Meaningful impact on global healthcare
- High-responsibility role
Startup-Atmosphäre
- Innovative environment
Weiterbildungsangebote
- Professional growth and development
- Training opportunities
- Development programs
Lockere Unternehmenskultur
- Culture of collaboration and knowledge sharing
- Teamwork
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Terumo Europe erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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TETerumo Europe
MSAT Senior Scientist(m/w/x)
Leverkusen
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading technology transfers and process validation for Pre-Filled Syringes (PFS) drug product manufacturing. 3+ years project leadership experience managing complex cGMP drug product projects required. High-responsibility role in an innovative environment.
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 or development projects
- Deep understanding of Drug Product technologies
- Familiarity with PFS, liquid and lyophilized vial filling
- Solid knowledge of regulatory requirements and pharmaceutical standards
- Strong experience with 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, 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 is an asset
- Experience with Minitab is an asset
Aufgaben
- Lead technology transfers and scale-up activities
- Support process validation for drug product manufacturing
- Focus on Pre-Filled Syringes (PFS) and full process chains
- Act as subject matter expert for drug product technologies
- Contribute to process and technology development
- Support operational excellence across the site
- 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 and contribute to continuous improvement
- Support new product introductions
- Lead risk assessments and define process control strategy
- 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 during tech transfer
- Share knowledge and build team capabilities
Berufserfahrung
- 3 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP Drug Product manufacturing
- Drug Product technologies
- PFS
- liquid and lyophilized vial filling
- EU GMP Annex 1
- validation
- risk assessments
- process characterization
- project management tools
- Minitab
Benefits
Attraktive Vergütung
- Market-competitive salary and benefits package
Karriere- und Weiterentwicklung
- Stability and career opportunities
Sinnstiftende Arbeit
- Meaningful impact on global healthcare
- High-responsibility role
Startup-Atmosphäre
- Innovative environment
Weiterbildungsangebote
- Professional growth and development
- Training opportunities
- Development programs
Lockere Unternehmenskultur
- Culture of collaboration and knowledge sharing
- Teamwork
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Terumo Europe erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Terumo Europe
Branche
Pharmaceuticals
Beschreibung
The company advances lifesaving medical technologies to benefit society and supports healthcare innovation.
Noch nicht perfekt?
- Merck & Co., Inc., Rahway, NJ, USA
Quality Assurance Lead(m/w/x)
Vollzeitnur vor OrtManagementKöln - MOMENTIVE PERFORMANCE MATERIALS GMBH
Sr Director Global Analytical & Process Technology(m/w/x)
Vollzeitnur vor OrtManagementLeverkusen - Lonza Cologne GmbH
Quality Site Head(m/w/x)
Vollzeitnur vor OrtSeniorKöln - Miltenyi Biotec
Leitung der Herstellung im Bereich Zell- und Gentherapie (CGT)(m/w/x)
Vollzeitnur vor OrtSeniorBergisch Gladbach - SUSONITY
(Sr.) Medical Science Liaison Rare Disease / Tumour(m/w/x)
Vollzeit/Teilzeitnur vor OrtSeniorMünchen, Köln, Gießen, Mainz, Frankfurt am Main, Göttingen, Erfurt, Leipzig, Dresden