Director of Bioanalytical Sciences
South San Francisco, California, United States
USD 173K-225K Executive-level Full Time
Tasks
- Author bioanalytical regulatory sections
- Collaborate cross functional teams on endpoints
- Define bioanalytical strategy for biologics
- Design interpret PK PD receptor occupancy studies
- Develop flow cytometry assays
- Develop ligand binding assays
- Ensure GLP and ICH M10 compliance
- Establish assay qualification validation frameworks
- Integrate PK PD exposure for candidate selection
- Lead bioanalytical method development qualification validation
- Manage CRO partnerships
- Review protocols validation plans data packages
Perks/Benefits
Skills/Tech-stack
Binding assays | Bioanalytical method development | Biomarker assays | DMPK Study Design | ECL | ELISA | Flow Cytometry | GLP | ICH M10 | Ligand binding | Ligand binding assays | MSD | Method Development | Method qualification | Method validation | PD modeling | PK/PD | PK/PD Modeling | Pharmacodynamics | Pharmacokinetics | Receptor Occupancy | Regulatory writing | Study design | Translational medicine
Education
Regions
Countries
States
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