Manufacturing Associate CAR-T
Manufacturing Associate CAR-T
Posted on :
31-12-2024
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1 Vacancy
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Job Description
- Perform aseptic Tcell culture processes including thawing cell separation selection reengineering 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 Tcell 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 TCellbased 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 crossfunctional 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.
Qualifications :
Have a Ph.D/MSc/BSc in a relevant area of Cell and Gene Therapy Biological Sciences or equivalent experience in the biotech industry.
Additional Information :
Technical Skills:
- Tcell 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. Tcell characterisationqPCR ddPCR NGS and cell culture metabolites).
- Experience in the use of and incorporation of automated manufacturing and semiautomated 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 fastpaced multidisciplinary industrial environment
In this exciting and fastpaced time for Cell and Gene Therapy Dr. Reddys 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 companys success.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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