Dein persönlicher KI-Karriere-Agent
Product Steward (m/w/x)
End-to-end process knowledge for drug substance manufacturing at a global pharmaceutical company. 5+ years GMP manufacturing experience required. Performance bonus, childcare facilities, worldwide career possibilities.
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Anforderungen
- Master’s degree in Biotechnology, Chemistry, Pharmacy, Chemical Engineering, or related scientific discipline
- Minimum 5 years of experience in GMP manufacturing, late-stage development, or QA/QC
- Strong understanding of upstream and downstream bioprocessing technologies
- Proven experience with computerized systems and data analysis tools
- Sound knowledge of regulatory requirements and industry guidelines
- Fluent English and German communication skills
- Applied Statistics, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer
Aufgaben
- Own product process knowledge throughout the commercial lifecycle
- Ensure continuously improving processes
- Maintain seamless knowledge flow across functions and sites
- Provide technical and scientific process support
- Maintain end-to-end process knowledge of drug substance manufacturing
- Act as the single point of contact for technology transfer through commercialization
- Support development and maintenance of process control strategy
- Support continuous improvement of process control strategy
- Monitor critical and key process variables through statistical analysis
- Evaluate critical and key process variables through regular product-specific trending
- Communicate process insights at site level
- Provide technical and process data for product transfer activities
- Define and execute necessary studies for product transfer
- Support Process Experts in troubleshooting activities
- Support Process Experts in root cause investigations
- Support Process Experts in implementing Corrective and Preventive Actions (CAPAs)
- Support Validation Leads in planning process validation activities
- Support Validation Leads in assessing process validation activities
- Support Process Experts in planning process validation activities
- Support Process Experts in assessing process validation activities
- Evaluate re-validation requirements
- Contribute to product registration strategies
- Support regulatory submissions
- Support lifecycle management activities
- Support site inspections
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Performance-based bonus
- Modern company pension scheme
- Childcare facilities
- Learning and development opportunities
- Worldwide career possibilities
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH 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.
Zur Originalanzeige bei Novartis Pharmaceutical Manufacturing GmbHÜber das Unternehmen
The company aims to reimagine medicine to improve and extend people’s lives.
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