Research Associate - CAR-T Upstream Manufacturing

• M.Sc. (specialization in any Life sciences) with 4- 10 years relevant experience
• Experience in aseptic processing in GMP Classification and cell culture is (at least in mammalian cell culture) required; experience in the automated T-cell culturing process, washing, harvesting, and Cryopreservation is preferred.
• Hands-on experience or understanding in developing, manufacturing CAR-T cell therapy products is preferred.
• Experienced/Participated in aseptic process simulation, proficient in aseptic techniques, especially in aseptic filling of drug products, Biosafety cabinet operations, clean room behaviors, sterile welding, sealing, sterile transfer, etc.
• Good exposure or understanding of QMS aspects (Change control, Risk Assessment, Deviation, Preparation of Investigation report, and CAPA).
• In-depth understanding of Cell & Gene Therapy Manufacturing/development and associated regulatory guidelines.

Roles & Responsibilities:

• Responsible for optimization of CAR cells manufacturing processes using normal human or patient-derived primary blood components, following ethical practices and QMS as per GMP guidelines
• Actively manufacture CAR-T cell therapy products by diligently prioritizing the lab functions to meet critical deadlines
• Establish and carefully execute transduction by viral vector and non-viral vector-based approaches, activation, and expansion of immune cells (T cells, NK cells, etc) isolated from clinical specimens without compromising sterility and quality parameters as per the guidelines and defined criteria by maintaining highest standards
• Able to communicate effectively in a highly matrixed team environment to advance the company's cell therapy pipeline
• Participate and assist in technical transfer and core R&D activities
• To review and prepare document SOPs, protocols, and reports pertaining to the program requirements
• Work closely with cross-functional teams to design and implement cell therapy processes and workflow for cell therapy platforms
• Provide critical technical/scientific recommendations for the manufacturing process improvements
• Work with vendors to evaluate raw materials and consumables for compatibility with the Manufacturing process
• Coordinate very closely with quality control, quality assurance, supply chain teams, etc, and strictly adhere to the project timelines by preserving integrity, accuracy, safety, and quality
• Prepare and participate in compliance monitoring inspections / regulatory agency interactions
• Able to troubleshoot experiments, record, analyze, interpret, and present the data in scientific meetings
• Understanding of systems and processes regarding sterile practices, work ethics, safety, health, and environment
• Ability to work off-shift and irregular hours as required

Competencies:

• CAR-T manufacture under GMP settings
• Proficient in Aseptic Operations
• Culture of T cells/NK cells and handling of viral vectors
• Statistical analysis, Presentation & Communication Skills
• Documentation and Report Writing
• Interpersonal Skills
• Team Player / Team Management