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Process Development Specialist
3 months ago
We are proud to be partnered with a company that collaborates with biotech scientists and engineers dedicated to curing some of the world’s most challenging diseases, including cancer, dementia, and inflammatory conditions. Through our partnership, we support the development and manufacturing of innovative medications, helping to bring life-saving treatments from concept to production, and ultimately making better medicine accessible to more people.
Position Overview: The Process Development Scientist will play a crucial role in the development and optimization of CAR-T cell therapies. The ideal candidate will have extensive experience in cell therapy processes, specifically CAR-T cell expansion, flow cytometry, and the use of bioreactors for cell culture. This role requires a deep understanding of ATMPs (Advanced Therapy Medicinal Products) and hands-on experience with bioreactor systems used in cell therapy production.
CAR-T Cell Expansion:
- Develop and optimize CAR-T cell expansion protocols from patient-derived blood samples, detailing each step from leukapheresis to final cell product.
- Monitor and improve critical bioreactor parameters to ensure optimal cell growth and viability during expansion.
Flow Cytometry:
- Design and execute flow cytometry assays for phenotypic characterization of CAR-T cells, ensuring accurate and reproducible results.
- Analyze and interpret flow cytometry data to guide process development and product quality.
Bioreactor Operation & Optimization:
- Operate and troubleshoot bioreactor systems for the expansion of CAR-T cells or similar cell therapy products.
- Identify and control key bioreactor parameters such as pH, dissolved oxygen, temperature, and agitation to optimize cell expansion and maintain product quality.
- Collaborate with cross-functional teams to scale up processes and transition from research to GMP manufacturing.
Process Documentation & Compliance:
- Document process development activities, including protocols, SOPs, and batch records, in compliance with regulatory standards.
- Ensure that all processes adhere to the highest standards of quality and regulatory compliance, particularly for ATMPs.
If you are on the lookout for an exciting new opportunity that will elevate your development and give you the chance to operate amongst some of the industries most talented professionals, look no further.
Please apply and I will be in touch to go through the role, your experience and everything else related in more detail.
until then, all the best.
