Senior Director, Analytical Development
Tasks
- Conduct batch data review
- Contribute to IND BLA and other regulatory submissions
- Define analytical development strategy
- Design and oversee stability programs
- Establish analytical control strategies
- Establish partner KPIs and continuous improvement
- Lead analytical development and external testing
- Lead comparability assessments
- Lead deviation investigation OOS OOT CAPA and change control resolution
- Manage CDMOs and contract testing laboratories
- Manage method development qualification validation
- Manage method lifecycle and reference standards
- Oversee GMP release testing
- Review and approve analytical methods specifications protocols and reports
- Support health authority responses and inspection readiness
- Support technology transfer and validation readiness
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Development | Analytical Method Development | Batch Record | Batch record review | CAPA | CMC | Change Control | Charge variant analysis | Chromatography | Comparability studies | Data Integrity | Data integrity principles | Deviation Management | ELISA | Electrophoresis | Fusion Proteins | GMP | Inspection Readiness | Integrity Principles | Material management | Method Development | Method qualification | Method transfer | Method validation | Monoclonal antibodies | OOS OOT | OOS OOT Investigation | OOT Investigation | Potency assays | Protein characterization | Quality Control | Recombinant Proteins | Record review | Reference Material Management | Reference standards | Regulatory Submissions | Size exclusion chromatography | Specifications | Spectroscopy | Stability Indicating Methods | Stability Testing | Technology Transfer | Variant analysis
Education
Regions
Countries
States
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