Director of Bioanalytical Sciences
South San Francisco, California, United States
USD 173K-225K Executive-level Full Time
Tasks
- Author and review regulatory bioanalytical sections
- Build assay qualification and validation framework
- Collaborate with cross-functional drug discovery teams
- Define bioanalytical strategy for biologics
- Design and interpret DMPK studies
- Develop PK PD receptor occupancy assays
- Develop optimize qualify validate bioanalytical methods
- Ensure GLP and ICH M10 compliance
- Integrate PK PD and exposure data for candidate selection
- Lead ligand binding assay development
- Manage CRO partnerships
- Review protocols validation plans and data packages
Perks/Benefits
Skills/Tech-stack
Assay qualification | Binding assays | Bioanalytical method validation | CRO Management | DMPK | ECL | ELISA | EMA regulations | FDA Regulations | Flow Cytometry | GLP | ICH M10 | IND Preparation | Ligand binding | Ligand binding assays | MSD | Method validation | Multiparameter flow cytometry | PD modeling | PK/PD | PK/PD Modeling | Pharmacodynamics | Pharmacokinetics | Receptor Occupancy | Translational pharmacology
Education
Regions
Countries
States
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