Dein persönlicher KI-Karriere-Agent
Director, Analytical Strategy(m/w/x)
Global analytical strategy development for biotherapeutics, including LC-MS/MS and immunogenicity testing. PhD or MSc with extensive experience required. Well-being support.
Anforderungen
- PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field, or MSc with extensive experience
- Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing
- Strong knowledge of regulatory requirements and analytical validation standards
- Proven leadership and strategic program experience
- Experience supporting regulatory submissions and health authority interactions
Aufgaben
- Develop and lead global analytical strategy
- Provide scientific and regulatory guidance
- Drive innovation in analytical technologies
- Represent analytical function in cross-functional forums
- Oversee development and validation of analytical methods
- Ensure high-quality data generation for studies
- Review and approve study designs and reports
- Troubleshoot complex scientific challenges
- Ensure compliance with global regulatory guidelines
- Lead regulatory submission sections
- Interface with regulatory agencies
- Maintain inspection readiness and quality standards
- Partner with clinical and translational teams
- Support dose selection decisions
- Manage external CROs and collaborators
- Lead and mentor analytical scientists
- Manage budgets and timelines
- Build and scale analytical capabilities
Berufserfahrung
- 12 - 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LC-MS/MS
Benefits
Mentale Gesundheitsförderung
- Well-being support
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- CSL Behring AG (CH)Vollzeitnur vor OrtSeniorBern
- CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Director, Process Development(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Scientist, Process Development, Tech Ops(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern
Director, Analytical Strategy(m/w/x)
Global analytical strategy development for biotherapeutics, including LC-MS/MS and immunogenicity testing. PhD or MSc with extensive experience required. Well-being support.
Anforderungen
- PhD in analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field, or MSc with extensive experience
- Deep expertise in LC-MS/MS, ligand binding assays, biomarkers, and immunogenicity testing
- Strong knowledge of regulatory requirements and analytical validation standards
- Proven leadership and strategic program experience
- Experience supporting regulatory submissions and health authority interactions
Aufgaben
- Develop and lead global analytical strategy
- Provide scientific and regulatory guidance
- Drive innovation in analytical technologies
- Represent analytical function in cross-functional forums
- Oversee development and validation of analytical methods
- Ensure high-quality data generation for studies
- Review and approve study designs and reports
- Troubleshoot complex scientific challenges
- Ensure compliance with global regulatory guidelines
- Lead regulatory submission sections
- Interface with regulatory agencies
- Maintain inspection readiness and quality standards
- Partner with clinical and translational teams
- Support dose selection decisions
- Manage external CROs and collaborators
- Lead and mentor analytical scientists
- Manage budgets and timelines
- Build and scale analytical capabilities
Berufserfahrung
- 12 - 15 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- LC-MS/MS
Benefits
Mentale Gesundheitsförderung
- Well-being support
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
Noch nicht perfekt?
- CSL Behring AG (CH)
Laboratory Specialist - Analytical Testing(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Stability Senior Scientist(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Director, Process Development(m/w/x)
Vollzeitnur vor OrtSeniorBern - CSL Behring
Scientist, Process Development, Tech Ops(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBern