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
Providing advanced technical expertise for biopharmaceutical stability programs. 3+ years of direct stability program development and management experience required. Support for junior scientists and continuous improvement activities.
Anforderungen
- Science degree (e.g. Bachelor, Master, PhD) in pharmacy, pharmaceutical technology, biology, chemistry or comparable education
- 3+ years experience in pharmaceutical manufacturing industry with direct exposure to Stability program development and management
- Good technical understanding of product lifecycle management in global biotech or pharmaceutical GMP environment
- Good grasp of current regulations and guidelines of stability monitoring of biopharmaceutical products
- Fluency in English in both writing and oral communications
- Provides training and technical guidance to junior scientists
- Aligns stability activities with departmental objectives
- Applies advanced statistical methods for decision-making
- Supports regulatory requests and cross-functional collaboration
- Operates effectively with minimal supervision in a global environment
Aufgaben
- Provide advanced technical expertise in stability science
- Support junior scientists
- Ensure a robust stability program
- Support regulatory requests
- Deliver continuous improvement activities
- Prepare protocols
- Compile data
- Generate detailed stability reports
- Lead data compilation and interpretation
- Present stability data
- Perform advanced statistical analysis
- Support decision-making with data extrapolation
- Train Stability Scientists in technical aspects
- Support lower-level regulatory requests
- Provide necessary documentation
- Coordinate with QC Operations for sample pulls
- Ensure timely testing and data entry into LIMS
- Conduct risk-based assessments
- Lead investigations into stability-related deviations
- Propose corrective actions
- Ensure compliance with GMP, ICH guidelines, and internal standards
- Use electronic systems for data management
- Understand regulatory requirements and stability principles
- Comprehend product stability profiles and key indicators
- Lead investigations and provide technical guidance
- Understand expected product profiles
- Conduct risk-based assessments
- Manage change control processes
- Deliver global stability activities
- Monitor progress of stability samples
- Identify and resolve issues impacting stability programs
- Work independently with initiative and accountability
- Support multiple projects
- Deliver objectives on time
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
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- CSL Behring AG (CH)
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CSCSL Behring
Stability Senior Scientist(m/w/x)
Bern
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Providing advanced technical expertise for biopharmaceutical stability programs. 3+ years of direct stability program development and management experience required. Support for junior scientists and continuous improvement activities.
Anforderungen
- Science degree (e.g. Bachelor, Master, PhD) in pharmacy, pharmaceutical technology, biology, chemistry or comparable education
- 3+ years experience in pharmaceutical manufacturing industry with direct exposure to Stability program development and management
- Good technical understanding of product lifecycle management in global biotech or pharmaceutical GMP environment
- Good grasp of current regulations and guidelines of stability monitoring of biopharmaceutical products
- Fluency in English in both writing and oral communications
- Provides training and technical guidance to junior scientists
- Aligns stability activities with departmental objectives
- Applies advanced statistical methods for decision-making
- Supports regulatory requests and cross-functional collaboration
- Operates effectively with minimal supervision in a global environment
Aufgaben
- Provide advanced technical expertise in stability science
- Support junior scientists
- Ensure a robust stability program
- Support regulatory requests
- Deliver continuous improvement activities
- Prepare protocols
- Compile data
- Generate detailed stability reports
- Lead data compilation and interpretation
- Present stability data
- Perform advanced statistical analysis
- Support decision-making with data extrapolation
- Train Stability Scientists in technical aspects
- Support lower-level regulatory requests
- Provide necessary documentation
- Coordinate with QC Operations for sample pulls
- Ensure timely testing and data entry into LIMS
- Conduct risk-based assessments
- Lead investigations into stability-related deviations
- Propose corrective actions
- Ensure compliance with GMP, ICH guidelines, and internal standards
- Use electronic systems for data management
- Understand regulatory requirements and stability principles
- Comprehend product stability profiles and key indicators
- Lead investigations and provide technical guidance
- Understand expected product profiles
- Conduct risk-based assessments
- Manage change control processes
- Deliver global stability activities
- Monitor progress of stability samples
- Identify and resolve issues impacting stability programs
- Work independently with initiative and accountability
- Support multiple projects
- Deliver objectives on time
Berufserfahrung
- 3 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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
Senior Production Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern