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Global analytical strategy development for biotherapeutics, including LC-MS/MS and immunogenicity testing. PhD or MSc with extensive experience required. Well-being support.
Requirements
- 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
Tasks
- 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
Work Experience
- 12 - 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LC-MS/MS
Benefits
Mental Health Support
- Well-being support
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Global analytical strategy development for biotherapeutics, including LC-MS/MS and immunogenicity testing. PhD or MSc with extensive experience required. Well-being support.
Requirements
- 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
Tasks
- 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
Work Experience
- 12 - 15 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- LC-MS/MS
Benefits
Mental Health Support
- Well-being support
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
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