Job Description

Company DescriptionDr. Reddyxe2x80x99s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Canxe2x80x99t Wait.Dr Reddys is seeking Manufacturing Associate Specialist specializing in cell therapy (CAR-T) programs. This position is part of our Manufacturing facility.The manufacturing role serves as an associate specialist in CAR-T production facility. You will work closely with our Research and Product Development, Quality teams to support the GMP Manufacturing operations, Technology transfer, risk assessments, quality, supply chain logistics and process validation of the CAR-T process across a wide range of novel modalities for Cell therapy programs.

• Perform aseptic T-cell culture processes, including thawing, cell separation, selection, re-engineering, expansion, and harvesting & formulating of cells in compliance with standard operating procedures (SOPs) and regulatory guidelines.
• Operate and maintain laboratory and manufacturing equipment such as T-cell handling systems, centrifuges, automation filling units, and cell counters, ensuring accurate performance and documentation(Commissioning, Qualification and AMC).
• Follow Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to ensure the quality and consistency of cell therapy products.
• Assist in developing and optimizing cell therapy manufacturing protocols to improve product quality, and efficiency.
• Maintain detailed and accurate records of manufacturing processes, experiments, and deviations in accordance with regulatory requirements.
• Manage and prepare raw materials, reagents, and components required for cell therapy production.
• Identify, analyse, and resolve technical issues during the manufacturing process to minimize downtime and ensure operational efficiency.
• Ensure adherence to regulatory requirements, including CDSCO, FDA, EMA, and other international standards, for the production of cell therapy products.
• Involvement in experiments for Manufacturing and process development and characterization of T-Cell-based gene modified cell processes to deliver robust platform processes.
• Support the process development team with performing routine processes, analytics and data analysis, such as flow cytometry, ddPCR, lentiviral vector titration.
• Work closely with cross-functional teams, including quality assurance, quality control, and process development, to meet project timelines and objectives.
• Training and Supervision: Train junior staff and new team members on manufacturing protocols, safety procedures, and GMP practices.
• Participate in compilation, review, editing and approval of batch records, standard operating procedures, development protocols and reports.
• Assist in lab management duties, stock management and equipment maintenance.
• Other activities may be assigned as required, in agreement with line management.

QualificationsHave a Ph.D/MSc/BSc in a relevant area of Cell and Gene Therapy, Biological Sciences or equivalent experience in the biotech industry.Additional InformationTechnical Skills:

• T-cell Engineering and Molecular level techniques: strong practical and theoretical experience, including experiment Analytical and project delivery.
• Have the ability to communicate effectively with teammates and collaborators, occasionally presenting work to large groups.
• Cellular assays and phenotyping (flow cytometry, cytotoxicity and cell viability testing).
• Molecular assays and biology (e.g. T-cell characterisation,qPCR, ddPCR, NGS and cell culture metabolites).
• Experience in the use of and incorporation of automated manufacturing and semi-automated workflows.

Behavioral Skills:

• Excellent interpersonal skills
• Outstanding organizational skills, with the ability to manage your time and multiple projects
• Excellent written and oral communication skills
• Creative problem solver
• Ability to operate in a fast-paced, multi-disciplinary industrial environment

In this exciting and fast-paced time for Cell and Gene Therapy, Dr. Reddy's offers a lively and active place to work. We believe in giving our employees the chance to work on projects that are important to the success and growth of our new modalities so that they can immediately make big impacts.We encourage everyone to be creative and maintain an open mind in order to contribute to the company's success.

Dr. Reddy's Laboratories