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Lead Scientist in Biologics Separation
2 months ago
Position Overview
The PDS&T Toxins team within the Operations Science & Technology - Biologics division plays a crucial role in supporting the manufacturing, process validation, regulatory submissions, and ongoing enhancements for late-stage and commercial production of biological toxin products.
Key Responsibilities
As a Lead Scientist specializing in Separations, you will:
- Drive the development, qualification, validation, and troubleshooting of separation techniques for biologics, including HPLC, capillary electrophoresis, and SDS-PAGE.
- Provide analytical support for process characterization and the manufacturing of advanced biological programs.
- Identify and implement continuous improvement initiatives, integrating new technologies to foster future business advancements.
- Author CMC analytical sections of regulatory submissions, including analytical methods, specifications, comparability assessments, and stability evaluations.
- Support regulatory inspections and respond to inquiries effectively.
- Present analytical development topics in cross-functional CMC meetings.
- Collaborate with diverse teams within the organization, maintaining strong relationships with internal and external partners.
- Conduct routine testing of in-process samples utilizing various separation methodologies.
- Troubleshoot issues encountered during routine testing, providing solutions to ensure the accuracy and reliability of results.
- Perform method validations in a GMP-compliant laboratory setting, ensuring adherence to regulatory standards. Author protocols, reports, and SOPs for both development and GMP laboratories.
