Job Description

CAR-T Cell Therapy Manufacturing Executive

Micro CRISPR Pvt Ltd is a leading biotechnology company dedicated to revolutionizing cancer treatment through advanced cell and gene therapy solutions. Our mission is to develop cutting-edge immunotherapies that transform patient outcomes. We are seeking a highly skilled and experienced CAR-T Cell Therapy Manufacturing Executives to work in our manufacturing operations and ensure the efficient production of high-quality cell therapy products.

Role Summary:

The CAR-T Cell Therapy Manufacturing Executives will work for the end-to-end manufacturing processes for CAR-T cell therapy manufacturing, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role requires strong knowledge of concepts of cell culture, operational expertise, and a deep understanding of cell therapy manufacturing.

Key Responsibilities:

Execution of the CAR-T cell therapy manufacturing process as per schedule
May have to work in shift and as per process
Monitoring and reviewing the qualification of equipment in cGMP facility.
Preparation and review of EOPs, SOPs and BMRs related to manufacturing process.
Preparation and review of EOPs, SOPs related to manufacturing facility.
Reporting the breakdown of any equipment in the manufacturing facility.
Manufacturing of CAR-T cells in cGMP environment and preparation of related documents as per quality compliance.
Coordination with QC for sharing of In-process and final product samples and preparation of associated documents.
Coordination with warehouse department for storage and issuance of raw material and finished product.
Coordination with QA department for timely completion of manufacturing related documents as per quality policy.
Actively contribute in the inventory management and procurement of reagent and consumables required for manufacturing.
Analyse the data and prepare the presentations of batch manufacturing.
Participate in the process development activities of CAR-T manufacturing process. Analyse data and prepare the reports and maintain related documents.
Timely completion of the documents related to cGMP manufacturing as per QA compliance.
Review the literature and participate in scientific discussions and presentations.

Requirement of skills:

Minimum of 1-2 years of industrial experience. Fresher's can also apply.
Proficiency in handling animal cell culture in biosafety cabinets. Candidates handled animal cell lines will be preferred
Preparation of media and buffers for animal cell culture
Concepts should be clear with respect to Immunology, cell culture, cancer, transformed and primary cell lines, etc
Basic understanding related to buffer preparation, cryopreservation and thawing of cells
Should have handled Biosafety cabinets, centrifuge, inverted microscope, cell counter, cell count by trypan blue staining, aseptic handling procedures, etc
Concepts related to genetic modification by transfection, transformation, and transduction should be clear.
Consepts related to genes, proteins, transcription, translation should be clear

Educational qualification:

Master degree in Biotechnology, Microbiology, Pharamceutics, etc