Roche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Full-timeOn-siteSenior
Basel
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RORoche
Global MSAT Senior Analytical Steward(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Analytical method transfers to CDMO networks for commercial manufacturing of life-changing healthcare solutions. Advanced degree and 7+ years industry experience in analytical procedure lifecycles required. Global collaboration across manufacturing sites with 30 days vacation.
Requirements
- Advanced degree in scientific discipline or related
- 7+ years relevant industry experience
- Knowledge of Analytical Procedure Lifecycle
- Understanding of ICH Q8 and M4
- Strong collaboration and communication skills
- Proactive, structured mindset
- Focus on quality, compliance, and reliability
- Flexibility for international collaboration hours
Tasks
- Oversee and drive Analytical Science and Technology activities
- Transfer analytical methods to the CDMO network
- Enable industrialization and reliable commercial manufacturing
- Ensure industrialization readiness and regulatory compliance
- Align analytical control strategies with manufacturing strategy
- Manage analytical method transfers for product launches
- Ensure effective knowledge transfer with partner sites
- Support analytical operations at CDMO QC laboratories
- Optimize and troubleshoot analytical methods
- Provide technical oversight during start-up and operations
- Oversee validation activities and define testing parameters
- Assess method performance and validation strategies
- Author and review technical and validation documents
- Prepare regulatory submissions for lifecycle management
- Ensure alignment with ICH M4 and submission requirements
- Contribute to cross-functional technical oversight teams
- Serve as subject matter expert in procedure lifecycle management
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH Q2
- ICH Q14
- Analytical Target Profile (ATP)
- ICH Q8
- ICH M4
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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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RORoche
Global MSAT Senior Analytical Steward(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Analytical method transfers to CDMO networks for commercial manufacturing of life-changing healthcare solutions. Advanced degree and 7+ years industry experience in analytical procedure lifecycles required. Global collaboration across manufacturing sites with 30 days vacation.
Requirements
- Advanced degree in scientific discipline or related
- 7+ years relevant industry experience
- Knowledge of Analytical Procedure Lifecycle
- Understanding of ICH Q8 and M4
- Strong collaboration and communication skills
- Proactive, structured mindset
- Focus on quality, compliance, and reliability
- Flexibility for international collaboration hours
Tasks
- Oversee and drive Analytical Science and Technology activities
- Transfer analytical methods to the CDMO network
- Enable industrialization and reliable commercial manufacturing
- Ensure industrialization readiness and regulatory compliance
- Align analytical control strategies with manufacturing strategy
- Manage analytical method transfers for product launches
- Ensure effective knowledge transfer with partner sites
- Support analytical operations at CDMO QC laboratories
- Optimize and troubleshoot analytical methods
- Provide technical oversight during start-up and operations
- Oversee validation activities and define testing parameters
- Assess method performance and validation strategies
- Author and review technical and validation documents
- Prepare regulatory submissions for lifecycle management
- Ensure alignment with ICH M4 and submission requirements
- Contribute to cross-functional technical oversight teams
- Serve as subject matter expert in procedure lifecycle management
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH Q2
- ICH Q14
- Analytical Target Profile (ATP)
- ICH Q8
- ICH M4
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Not a perfect match?
- Roche
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