Director, Bioanalytics
San Francisco, California, United States
USD 203K-284K Executive-level Full Time
Tasks
- Coordinate cross functional sample analysis support
- Develop and optimize immunoassays and bioassays
- Execute neutralizing antibody assays
- Implement GxP compliant quality documentation
- Manage CRO selection qualification auditing and execution
- Manage and mentor bioanalytical team
- Prepare regulatory data packages and draft regulatory responses
- Review and approve assay validation plans and reports
- Serve as sponsor representative for method transfer and qualification
- Transfer methods to contract research organizations
- Validate analytical methods for pharmacokinetic pharmacodynamic and ADA
Perks/Benefits
- 401k match
- Commuter benefits
- Company-Paid Holidays
- Health insurance
- Lunch provided
- Non Accrued Paid Time Off
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | 21 CFR Part 210 | 21 CFR Part 211 | ADA Assay | Bioassay | CFR Part 11 | Excel | GLP | GxP | Immunoassay | JMP | Method validation | Minitab | Neutralizing Antibody | Part 11 | Part 210 | Part 211 | Pharmacodynamics | Pharmacokinetics | Quality Systems | Statistical Analysis
Education
Regions
Countries
States
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