Company Description: An innovative company specializing in advanced immunotherapy and engineered...
Company Description:
An innovative company specializing in advanced immunotherapy and engineered T-cell therapies is seeking a Senior Analytical Scientist to strengthen its Quality Control (QC) team. The organization operates in a fast-paced, science-driven environment focused on transforming cancer treatment through personalized therapies.
Role Description:
In this position, you will support the manufacturing and release of cell therapy products by leading analytical method implementation, validation, and technology transfers within QC. You will play a key role in ensuring GMP compliance and maintaining high-quality standards for advanced therapeutic products.
Responsibilities:
- Lead implementation and transfer of new analytical methods and technologies
- Develop and validate analytical procedures and documentation
- Oversee assay validation, automation systems, and troubleshooting activities
- Manage OOS investigations, deviations, and CAPA processes
- Monitor analytical and stability data to ensure quality compliance
- Collaborate with global teams and external manufacturers
- Drive continuous improvement initiatives within QC operations
Requirements:
- MSc with 8+ years of industry experience or PhD with 5+ years
- Strong expertise in flow cytometry, ELISA, PCR, and bioassays
- Solid knowledge of cGMP/GLP standards
- Strong project management, analytical, and communication skills
- Proficiency in MS Office (Excel); JMP knowledge is a plus
Other information:
If you are interested in this opportunity, please apply via the application link and feel free to contact me for more information.