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 protocols and validation reports
- Define critical quality attributes and analytical control strategies
- Develop qualify and execute PCR based methods for nucleic acid quantitation
- Ensure GMP GLP and HSE compliance for analytical work
- Execute assay qualification verification and validation per ICH Q2R2
- Maintain electronic laboratory notebook and documentation
- Perform gel electrophoresis blotting and restriction analysis
- Provide technical input on externally generated data packages
- Qualify and validate immunoassay methods
- Support method transfer comparability studies and data review
- Support stability study design and execution for DS and DP
- Transfer analytical methods to CRO CMO and manufacturing sites
Perks/Benefits
- 401k
- Employee assistance program
- Fitness benefits
- Life insurance
- Medical/Dental/Vision insurance
- Vacation benefits
- Well-being benefits
Skills/Tech-stack
AAV | Analytical Method Verification | Analytical method validation | Assay qualification | Benchling | Bioinformatics | Blotting | CMO management | CRO Management | Critical Quality Attributes | DPCR | Data Management | DdPCR | ELISA | Electronic Laboratory | Electronic Laboratory Notebook | GLP | GMP | Gel electrophoresis | Gyrolab | HSE | ICH Q2R2 | Immunoassay | LVV | Laboratory Notebook | Library preparation | MSD | Method transfer | Method validation | Method verification | NGS Library Preparation | Next-Generation Sequencing | QPCR | Quality attributes | Residual DNA Quantitation | Restriction Enzyme | Restriction Enzyme Analysis | Vector genome titration | Viral Vector | Viral vector genome titration
Education
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