CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSenior
Bern
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
CSCSL Behring
Stability Senior Scientist(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Advanced technical expertise in stability science for biotherapeutics, supporting junior scientists and regulatory requests. Science degree and global biotech GMP environment understanding required. Well-being support and continuous improvement activities in a global team.
Anforderungen
- Science degree in pharmacy, pharmaceutical technology, biology, chemistry, or comparable
- Technical understanding of product lifecycle management in global biotech/pharmaceutical GMP environment
- Grasp of current regulations/guidelines for stability monitoring of biopharmaceutical products
- Fluency in English (writing and oral)
- Knowledge/skill sharing: Training and technical guidance to junior scientists
- Strategic Thinking: Aligning stability activities with departmental objectives
- Analytical Skills: Applying advanced statistical methods for decision-making
- Impact and Engagement: Supporting regulatory requests and cross-functional collaboration
- Self-Management: Operating effectively with minimal supervision in a global environment
Aufgaben
- Provide advanced technical expertise in stability science
- Support junior scientists in stability programs
- Ensure robust stability program and support regulatory requests
- Deliver continuous improvement activities in a global team
- Prepare protocols and compile data for stability studies
- Generate detailed stability reports and identify trends
- Perform advanced statistical analysis and data extrapolation
- Train Stability Scientists in technical and knowledge-based aspects
- Support lower-level regulatory requests and provide documentation
- Coordinate with QC Operations for timely sample pulls and testing
- Enter data into LIMS and ensure accuracy
- Conduct risk-based assessments with Principal Stability Scientist
- Lead investigations into stability-related deviations
- Propose corrective actions for stability issues
- Ensure compliance with GMP, ICH guidelines, and internal standards
- Use electronic systems (LIMS, Statistica) for data management
- Understand regulatory requirements and stability principles
- Comprehend product stability profiles and key indicators
- Lead investigations and provide technical guidance
- Demonstrate good product knowledge and expected profiles
- Understand risk-based assessments and change control processes
- Deliver global stability activities and ensure timely execution
- Monitor progress of stability samples with QC Operations
- Identify and resolve issues impacting stability programs
- Work independently with initiative and accountability
- Support multiple projects and meet deadlines
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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.
Noch nicht perfekt?
- CSL Behring AG (CH)
Senior Scientist, Tech Ops(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
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Vollzeitnur vor OrtSeniorBern - Bavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
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Laboratory Specialist - Technical Operations(m/w/x)
Vollzeitnur vor OrtSeniorBern
CSCSL Behring
Stability Senior Scientist(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Advanced technical expertise in stability science for biotherapeutics, supporting junior scientists and regulatory requests. Science degree and global biotech GMP environment understanding required. Well-being support and continuous improvement activities in a global team.
Anforderungen
- Science degree in pharmacy, pharmaceutical technology, biology, chemistry, or comparable
- Technical understanding of product lifecycle management in global biotech/pharmaceutical GMP environment
- Grasp of current regulations/guidelines for stability monitoring of biopharmaceutical products
- Fluency in English (writing and oral)
- Knowledge/skill sharing: Training and technical guidance to junior scientists
- Strategic Thinking: Aligning stability activities with departmental objectives
- Analytical Skills: Applying advanced statistical methods for decision-making
- Impact and Engagement: Supporting regulatory requests and cross-functional collaboration
- Self-Management: Operating effectively with minimal supervision in a global environment
Aufgaben
- Provide advanced technical expertise in stability science
- Support junior scientists in stability programs
- Ensure robust stability program and support regulatory requests
- Deliver continuous improvement activities in a global team
- Prepare protocols and compile data for stability studies
- Generate detailed stability reports and identify trends
- Perform advanced statistical analysis and data extrapolation
- Train Stability Scientists in technical and knowledge-based aspects
- Support lower-level regulatory requests and provide documentation
- Coordinate with QC Operations for timely sample pulls and testing
- Enter data into LIMS and ensure accuracy
- Conduct risk-based assessments with Principal Stability Scientist
- Lead investigations into stability-related deviations
- Propose corrective actions for stability issues
- Ensure compliance with GMP, ICH guidelines, and internal standards
- Use electronic systems (LIMS, Statistica) for data management
- Understand regulatory requirements and stability principles
- Comprehend product stability profiles and key indicators
- Lead investigations and provide technical guidance
- Demonstrate good product knowledge and expected profiles
- Understand risk-based assessments and change control processes
- Deliver global stability activities and ensure timely execution
- Monitor progress of stability samples with QC Operations
- Identify and resolve issues impacting stability programs
- Work independently with initiative and accountability
- Support multiple projects and meet deadlines
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CSL Behring 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.
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
- CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring AG (CH)
Senior Scientist, Tech Ops(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Senior Scientist (Pathogen Safety Support)(m/w/x)
Vollzeitnur vor OrtSeniorBern - Bavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Laboratory Specialist - Technical Operations(m/w/x)
Vollzeitnur vor OrtSeniorBern