Cell Therapy Process Development Specialist
3 weeks ago
We are seeking a highly motivated MSAT scientist to play a critical role in cell therapy product tech transfer in a cGMP environment. The ideal candidate will have a strong background in cell biology, engineering, molecular biology, or a related discipline, with experience in cell therapy process development and tech transfer.
Key Responsibilities:
- Coordinate with internal and external stakeholders to transfer end-to-end engineered cell therapy manufacturing process into cGMP clinical production.
- Collaborate with internal key stakeholders to provide sound technical guidance and drive successful clinical production.
- Identify available cutting-edge technologies to drive cell therapy process optimization and scale-up solutions to reduce clinical production cost of goods.
- Author technical reports and CMC related regulatory sections to support regulatory submission and provide technical support to address regulatory inquiries.
- Provide technical training and coaching to junior team members to execute the manufacturing process in PD labs and cGMP facility.
- Lead process deviation investigation, impact assessment, and author related reports.
- Support cGMP operation and process/manufacturing fit assessment/gap analysis of equipment, facilities, and processes.
- Track trending clinical production performance to drive process improvement and ensure process operation within intended control strategy.
- PhD in cell biology, engineering, molecular biology, pharmaceutical chemistry, or a related discipline with 1-3 years wet lab experience (academic or industry) or master's degree with minimal 3 years of industry experience or minimal 5 years industry experience for BS.
- Industry experience and strong hands-on skills in cell therapy process development and tech transfer are required. Direct experience in Tumor-infiltrating lymphocyte (TIL) therapy is strongly preferred.
- Demonstrated experience and hands-on skills in tumor tissue dissociation, cell isolation, transduction, expansion, and cryopreservation operation in PD and cGMP environment.
- Demonstrated knowledge and understanding of cGMP requirements, ICH, and regulatory guidelines.
- Demonstrated ability to drive sound decision-making in the cGMP environment.
- Experience in cell analytical method development and qualification, including flow cytometry, qPCR, and cytotoxicity assay, is a strong plus.
- Organizational, multi-tasking, and communication skills.
- Able to collaborate and a good team player.
- Able to work in a fast and dynamic environment.
Why uBriGene?
At uBriGene, we offer an innovative and collaborative work environment where you will contribute to the cutting-edge development of cell and gene therapies. We are passionate about fostering professional growth and delivering impactful solutions for our clients.
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