Principal Scientist, Early In-Process Analytics, Biotherapeutics Process Development, Pharmaceutical Sciences
Tasks
- Align analytical methods data formats reporting and workflows with global partners
- Design and execute analytical experiments for process characterization and troubleshooting
- Develop strategy standards and testing plans for early stage process development
- Drive continuous improvement in IPA workflows sample handling turnaround time and documentation practices
- Execute method qualification verification and validation for GMP testing
- Maintain data integrity and sample chain of custody
- Manage analytical method transfer and implementation
- Prepare technical reports and documentation for regulatory submissions
- Provide technical guidance and training for new assays
- Provide technical leadership for early in process analytics
- Serve as subject matter expert for protein based large molecule in process testing
- Support commissioning and qualification of laboratory and process analytics equipment and data systems
Perks/Benefits
- N/A
Skills/Tech-stack
Analytical Experimentation | Analytical Method Development | Analytical equipment | Analytical equipment qualification | Analytical testing | Automation systems | CGMP | Chain of Custody | Commissioning and qualification | Data Integrity | Data Science | Digitalization | Document Writing | Equipment qualification | GMP | ICH | In Process Analytics | In-silico modeling | Lab Automation | Large molecule analytics | Method Development | Method qualification | Method transfer | Method validation | Method verification | Process analytics | Process characterization | Protein characterization | Regulatory document writing | Risk Assessment | Scale Up | Scale up support | Statistical Analysis | Technical reporting | Troubleshooting
Education
Roles
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