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Senior Scientist / Senior Engineer, Process And Analytical Development
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- The Company Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities.
- This entails independently performing and/or managing day-to-day process development activities in conjunction with team members, project leaders, and customers to enable cGMP production of pre-clinical and clinical-grade biologics, including therapeutic proteins, cell-based therapies, and plasmid and viral vectors at Scorpius BioManufacturing.
- Key Responsibilities Assist in the development and optimization of upstream biologics (mammalian and bacterial)/cell therapy production processes that follow FDA and/or appropriate global regulations and guidelines.
- This includes transfer of processes into the cleanroom environment, process troubleshooting and, in collaboration with the Biomanufacturing Operations team, generation of all relevant cGMP documentation (Batch Records, Compounding Records, Operating Procedures, etc
- Support Quality Assurance group by assisting in employee training, document control, validation support, calibration and preventative maintenance support, change control deviation reporting, CAPA, risk analysis, etc.
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