Manufacturing Specialist CAR-T – in Bengaluru at Dr. Reddy’s, Apply Now!
Dr. Reddy’s Laboratories Ltd. is hiring a Manufacturing Specialist (CAR-T) to support cell therapy manufacturing, GMP operations, technology transfers, and process validation. If you have 4–15 years of experience in Cell & Gene Therapy or Biologics Manufacturing, this is your opportunity to contribute to cutting-edge CAR-T therapy development. Apply today!
Job Posting: Manufacturing Specialist (CAR-T)
Location: s="c-spl-job-location__place">Bengaluru, Karnataka, India
Job Family: Manufacturing
Sub Job Family: Production – Biosimilar (Drug Product)
Business unit: Biologics
Role Responsibilities
As a Manufacturing specialist, 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 as Manufacturing Specialist .
- 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 Manufacturing Specialist .
- 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.
Qualifications for Manufacturing Specialist:
PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology, or a relevant life-science discipline, with 4–15 years of industry experience in Cell and gene therapy, biologics manufacturing/product development functions.
Additional Information
Manufacturing Specialist: 4-10 years of relevant experience in Cell therapy/biologics.
Senior Manufacturing Specialist: 8-15 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 preferred for Manufacturing Specialist.
- 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.
Keywords: Manufacturing Specialist, CAR-T, Cell therapy, Biologics, GMP, SOPs, Cell Culture, Technology Transfer
