CSL Behring
Stability Senior Scientist(m/w/x)
Full-timeOn-siteSenior
Bern
New Job?Nejo!
Your personal AI career agent
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
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.
Not a perfect match?
- 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
Senior Production Scientist(m/w/x)
Full-timeOn-siteSeniorBern
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
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
Senior Production Scientist(m/w/x)
Full-timeOn-siteSeniorBern