Manufacturing Specialist

Micro Crispr Pvt. Ltd.; Vapi; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Micro CRISPR Pvt Ltd, a leading biotechnology company in Vapi, Gujarat, seeks an experienced CAR-T Cell Therapy Manufacturing Executive to oversee end-to-end production of CAR-T cell therapies in a cGMP environment.

The role requires solid knowledge of cell culture, GMP concepts, and data-driven manufacturing, with responsibilities spanning documentation, equipment qualification, and cross-functional coordination to ensure timely batch completion.

Qualifications

• Experience with animal cell culture in biosafety cabinets.
• Familiar with media/preparation for cell culture.
• Understanding of immunology, cancer biology, cell lines.

Responsibilities

• Execute CAR-T manufacturing processes as per schedule.
• Work in shifts if required and ensure process compliance.
• Monitor equipment qualification in cGMP facility.
• Prepare and review EOPs, SOPs, and BMRs for manufacturing.
• Coordinate with QC/QA/warehouse for samples, documents and materials.
• Analyze data and prepare batch manufacturing reports.

Skills

Cell culture

GMP knowledge

Biosafety cabinets

T cell therapy

Transfection basics

Data analysis

Job description

CAR-T Cell Therapy Manufacturing Executive

Job Location - Vapi Gujarat

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