CSL Behring
Senior Scientist, Molecular Characterization and Method Development(m/w/x)
Full-timeOn-siteSenior
Bern
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Developing binding, enzymatic, and cell-based bioassays for biologics, with focus on ELISA, SPR/BLI, and MoA-linked assays. PhD and industry experience in assay development required. Well-being support and mentoring opportunities.
Requirements
- PhD in Biochemistry, Molecular Biology, Biotechnology, Immunology, or related discipline (or equivalent experience)
- Industry experience developing binding, enzymatic, and/or cell-based assays for biologics
- Expertise in potency assay development and MoA-linked bioassays
- Working knowledge of ICH Q2(R2), ICH Q14, and regulatory expectations for bioassays
- Experience supporting regulatory submissions and inspections
- Scientific leadership, mentoring, and cross-functional influence
Tasks
- Design and develop binding, enzymatic, and cell-based assays
- Qualify and manage assay lifecycles
- Provide deep technical expertise for complex bioassays
- Mentor scientists and influence cross-functional CMC strategy
- Optimize binding assays (e.g., ELISA, SPR/BLI), enzymatic assays, and cell-based bioassays
- Define assay strategy aligned to MoA, CQAs, and clinical phase
- Select reference materials, controls, and acceptance criteria
- Resolve complex assay challenges (variability, matrix effects, specificity, drift, biological relevance)
- Drive assay robustness and mechanistic understanding
- Author and approve Analytical Target Profiles (ATP), Method Development reports, and Pre-qualification reports
- Ensure methods are phase-appropriate and support comparability, tech transfer, and post-approval changes
- Provide scientific oversight for method troubleshooting and OOS/OOT investigations
- Evaluate and implement new assay technologies and platforms (e.g., automation, digital data capture, novel readouts)
- Champion continuous improvement in assay throughput, reproducibility, and data integrity
- Partner with automation, data, and IT teams to modernize bioassay workflows
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- ICH Q2(R2)
- ICH Q14
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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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Developing binding, enzymatic, and cell-based bioassays for biologics, with focus on ELISA, SPR/BLI, and MoA-linked assays. PhD and industry experience in assay development required. Well-being support and mentoring opportunities.
Requirements
- PhD in Biochemistry, Molecular Biology, Biotechnology, Immunology, or related discipline (or equivalent experience)
- Industry experience developing binding, enzymatic, and/or cell-based assays for biologics
- Expertise in potency assay development and MoA-linked bioassays
- Working knowledge of ICH Q2(R2), ICH Q14, and regulatory expectations for bioassays
- Experience supporting regulatory submissions and inspections
- Scientific leadership, mentoring, and cross-functional influence
Tasks
- Design and develop binding, enzymatic, and cell-based assays
- Qualify and manage assay lifecycles
- Provide deep technical expertise for complex bioassays
- Mentor scientists and influence cross-functional CMC strategy
- Optimize binding assays (e.g., ELISA, SPR/BLI), enzymatic assays, and cell-based bioassays
- Define assay strategy aligned to MoA, CQAs, and clinical phase
- Select reference materials, controls, and acceptance criteria
- Resolve complex assay challenges (variability, matrix effects, specificity, drift, biological relevance)
- Drive assay robustness and mechanistic understanding
- Author and approve Analytical Target Profiles (ATP), Method Development reports, and Pre-qualification reports
- Ensure methods are phase-appropriate and support comparability, tech transfer, and post-approval changes
- Provide scientific oversight for method troubleshooting and OOS/OOT investigations
- Evaluate and implement new assay technologies and platforms (e.g., automation, digital data capture, novel readouts)
- Champion continuous improvement in assay throughput, reproducibility, and data integrity
- Partner with automation, data, and IT teams to modernize bioassay workflows
Work Experience
- approx. 4 - 6 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- ICH Q2(R2)
- ICH Q14
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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
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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