Advisor - Molecular Biology, Analytical Development - BR&D
US: Indianapolis IN Tech Center North, United States
USD 126K-244K Mid-level Full Time
Tasks
- Author and review analytical methods and validation reports
- Conduct gel electrophoresis blotting and restriction enzyme analysis
- Contribute to CMC submissions technical content
- Define critical quality attributes and analytical control strategies
- Develop qualify and execute PCR based methods
- Ensure analytical work complies with GMP and GLP
- Maintain electronic laboratory notebook documentation
- Perform assay qualification verification and validation
- Perform viral vector genome titration and residual DNA quantitation
- Support stability study design and execution
- Support technical review of external analytical data
- Transfer analytical methods to CRO CMO and manufacturing sites
- Use immunoassay platforms for residual host cell protein and impurity testing
Perks/Benefits
- N/A
Skills/Tech-stack
Assay validation | Blotting | Critical Quality Attributes | DPCR | DdPCR | ELISA | Electronic Laboratory | Electronic Laboratory Notebook | GLP | GMP | Gel electrophoresis | ICH Q2 | ICH Q2 R2 | Immunoassay | Laboratory Notebook | Method transfer | Nucleic Acid Analytics | PCR | QPCR | Quality attributes | Residual DNA Quantitation | Restriction Enzyme Analysis | Stability Studies | Vector analytics | Viral Vector | Viral Vector Analytics
Education
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