Roche
Global MSAT Senior Analytical Steward(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RORoche
Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-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 Roche 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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Principal Analytical Steward - gMSAT Small Molecules(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Master-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 Roche 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Roche
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
Noch nicht perfekt?
- Roche
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