CSL Behring
Stability Senior Scientist(m/w/x)
Full-timeOn-siteSenior
Bern
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Not a perfect match?
- CSL Behring
Stability Senior Scientist(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring AG (CH)
Senior Scientist, Tech Ops(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Senior Scientist (Pathogen Safety Support)(m/w/x)
Full-timeOn-siteSeniorBern - Bavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Full-timeOn-siteSeniorBern - CSL Behring
Laboratory Specialist - Technical Operations(m/w/x)
Full-timeOn-siteSeniorBern