Roche
Global MSAT Senior Analytical Steward(m/w/x)
Full-timeOn-siteSenior
Basel
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RORoche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Building commercial analytical subteam structures for small molecule drug development. Matrix leadership and 10+ years of analytical method development experience required. Collaboration across analytics, technical development, and external quality teams.
Requirements
- Significant cross-functional matrix leadership experience
- Ability to architect and shape in complex, ambiguous environments
- M.S. degree in chemistry, pharmacy, engineering, or related technical field
- PhD is an advantage
- 10+ years industry experience in analytical method development, validation, or QC support
- In-depth knowledge of Analytical Lifecycle (ICH Q2, Q14)
- Application of Analytical Lifecycle to synthetic molecules
- Definition of Analytical Target Profile (ATP)
- Impurity characterization and control strategy development
- Demonstrated experience with ICH Q8 and ICH M4 expectations
- Alignment of regulatory submissions and control strategy with manufacturing process
- Experience supporting DS and DP analytical activities at CDMOs
Tasks
- Build robust, scalable, and future-ready commercial Analytical Subteam structure
- Connect Centers of Analytics, Technical Development, and External Quality to gMSAT
- Implement and execute new cAST (Commercial Analytical Sub Team)
- Provide matrix leadership to analytical experts within gMSAT SM
- Foster collaboration and technical alignment among analytical experts
- Shape and influence global strategic processes
- Establish harmonized analytical standards
- Develop long-term strategy to harmonize processes and foster collaboration
- Strengthen quality assurance, regulatory compliance, and efficiency for Synthetic Molecules
- Serve as Business Process Owner (BPO) for commercial products
- Act as key interface between Center of Analytics, global Quality, and gMSAT
- Define and drive implementation of coordinated strategic processes
- Matrix lead gMSAT analytical SMEs and lead analytical sub-teams for commercial synthetic molecule products
- Organize and lead regular meetings with Center of Analytics, global QC, and R&D
- Share best practices and further develop processes
- Support and drive methodical or procedural improvements
- Manage Analytical Control Lifecycle for commercial synthetic molecule products
- Transfer analytical methods to CDMOs for Drug Substance, Starting Materials, and Intermediates
Work Experience
- 10 years
Education
- Master'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 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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- Lonza
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Principal DP (Drug Product) Product Steward - Global MSAT(m/w/x)
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Global MSAT Senior Product & Process Steward(m/w/x)
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Analytical Associate in Process Development Analytics for Synthetic Molecules(m/w/x)
Full-timeOn-siteSeniorBasel
RORoche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Building commercial analytical subteam structures for small molecule drug development. Matrix leadership and 10+ years of analytical method development experience required. Collaboration across analytics, technical development, and external quality teams.
Requirements
- Significant cross-functional matrix leadership experience
- Ability to architect and shape in complex, ambiguous environments
- M.S. degree in chemistry, pharmacy, engineering, or related technical field
- PhD is an advantage
- 10+ years industry experience in analytical method development, validation, or QC support
- In-depth knowledge of Analytical Lifecycle (ICH Q2, Q14)
- Application of Analytical Lifecycle to synthetic molecules
- Definition of Analytical Target Profile (ATP)
- Impurity characterization and control strategy development
- Demonstrated experience with ICH Q8 and ICH M4 expectations
- Alignment of regulatory submissions and control strategy with manufacturing process
- Experience supporting DS and DP analytical activities at CDMOs
Tasks
- Build robust, scalable, and future-ready commercial Analytical Subteam structure
- Connect Centers of Analytics, Technical Development, and External Quality to gMSAT
- Implement and execute new cAST (Commercial Analytical Sub Team)
- Provide matrix leadership to analytical experts within gMSAT SM
- Foster collaboration and technical alignment among analytical experts
- Shape and influence global strategic processes
- Establish harmonized analytical standards
- Develop long-term strategy to harmonize processes and foster collaboration
- Strengthen quality assurance, regulatory compliance, and efficiency for Synthetic Molecules
- Serve as Business Process Owner (BPO) for commercial products
- Act as key interface between Center of Analytics, global Quality, and gMSAT
- Define and drive implementation of coordinated strategic processes
- Matrix lead gMSAT analytical SMEs and lead analytical sub-teams for commercial synthetic molecule products
- Organize and lead regular meetings with Center of Analytics, global QC, and R&D
- Share best practices and further develop processes
- Support and drive methodical or procedural improvements
- Manage Analytical Control Lifecycle for commercial synthetic molecule products
- Transfer analytical methods to CDMOs for Drug Substance, Starting Materials, and Intermediates
Work Experience
- 10 years
Education
- Master'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 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.
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
Global MSAT Senior Analytical Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Lonza
Principal Scientist-Analytical Project Leader(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Principal DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Global MSAT Senior Product & Process Steward(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Analytical Associate in Process Development Analytics for Synthetic Molecules(m/w/x)
Full-timeOn-siteSeniorBasel