Manufacturing Specialist CAR-T
2 weeks ago
Dr Reddys is seeking Manufacturing Scientists or senior scientists specializing in cell therapy (CAR-T) programs. This position is part of our Manufacturing facility.
The manufacturing role serves as a Scientist in CAR-T production facility. You will work closely with our Research and Product Development teams to support the GMP Manufacturing operations, Technology transfer, quality assessments, and supply chain logistics and process validation of the CAR-T process across a wide range of novel modalities for Cell therapy programs.
Role Responsibilities:
As a Manufacturing scientist or senior scientist, a typical day might include the following:
- Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development/commercialization.
- Lead and train a team of cell process scientists/engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals.
- Manage and/or execute T-cell culture and differentiation to support process development, characterization, and validation.
- Manage troubleshooting with a high degree of complexity.
- Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter/result ranges.
- Support the development of SOPs and batch records, risk assessments as well as the technology transfers.
- Review completed production batch records and assist with deviations, CAPAs, Change Controls, and investigations.
- Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.
- Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and support/lead projects with a fully integrated team to facilitate successful outcomes.
- Serve as an internal technical subject matter expert and support technology transfers, engineering, and PV batches.
- Coordinate resources and set priorities for own/team, contributing to the overall goals of the department.
- Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable.
- Align with leadership to develop strategic roadmap on continuous medium optimization and phase-appropriate medium development and implementation.
- Manage the medium development team to ensure timely delivery of cell culture medium development and optimization projects.
- Empower and support junior team members to independently plan and design experiments. Continuously grow and encourage team members on scientific and critical thinking.
PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology or a relevant life-science discipline, with relevant 5–12 years of industry experience within Cell and gene therapy, biologics manufacturing/product development functions.
Additional InformationManufacturing Scientist: 4-7 years of relevant experience in Cell therapy/ biologics
Senior Manufacturing Scientist: 8-12 years of relevant experience in Cell Therapy/ Biologics
- Experience in aseptic processing in GMP classification and cell culture is required. Experience in automated equipment for cell culture, washing, and cryopreservation is preferred.
- Experience independently conducting and directing the design, execution, analysis, and documentation of T-cell culture processes for cell therapy products and or biologics.
- You can comfortably work in a dynamic, fast-paced, closely collaborative environment, on multiple projects in parallel, independently or as a group.
- Willingness to support a team of manufacturing scientists/engineers/QC/MSAT.
- Experience in evaluating and introducing novel technology platforms into process development and commercial manufacturing.
- Experience in the design of experiments (DOE) and statistical analysis.
- Working knowledge of GMP requirements. Make clear and timely decisions to address challenges and drive the Manufacturing department towards success.
- Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
- Strong organizational skills and high attention to detail.
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