The Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) is the state of art of R&D wing of the Tata Memorial Centre. It is located in the picturesque settings at the foot hills of the Sahyadri mountains in Kharghar, Navi Mumbai. ACTREC comprises of, the Cancer Research Institute (CRI), Clinical Research Centre (CRC) and Centre for Cancer Epidemiology (CEC), a setting that is unique in India and built and evolved with a vision to provide comprehensive cancer care to one and all, through its motto of excellence in services, education and research.
ONLINE INTERVIEW FOR AD-HOC SCIENTIFIC OFFICER ‘D’ (CAR T Cell Therapy Centre) ON CONTRACT BASIS
Qualification and Experience:
ESSENTIAL: Ph.D. in Biochemistry / lmmunology with a minimum of 3 years experience in CAR T Cell Therapy, GMP grace Clinical manufacturing of Cell Therapy Based Medicinal Products and working in a GMP Cell Therapy Clinical Centre / Unit. Experience in Clinical Manufacturing of CAR T cells, NK cells, and other forms of cell based medicinal products.
- The candidate should have experience in Clinical Manufacturing of CAR T cells, NK cells, and other forms - of cell based medicinal products.
- The candidate should have received Training in different types Cellular Therapy Processes & Services
- Training in Cleanroom Design and Development
- Knowledge & training in all processes related to Chemistry Manufacturing and Records of CAR T cell therapy and other CBMPs as per International & national guidelines.
- Experience in Validation, Quality Control, Quality Assurance of the cGMP based Cellular Processes.
- Trained & experience in regulatory framework for Cellular Therapies in India for Phase l/ll Clinical Trials.
- Experience with immunotherapies like CAR T cell therapy and oncology related cell types including subset of T cells, NK cells, macrophages, VSTs
- The candidate should have experience on working with GMP grade closed automated Cell processing Equipment’s like Clinimax, Prodigy, Sepax , Xuri etc.
Preferred
- Knowledge of all cGMP regulations and FDA/EU/GTP guidance applicable to Biologies and Cell Therapy manufacturing
- Handling human derived materials in IS07/IS08 clean room facility, cell expansion and automated cell processing equipment.
- Experience in Clean room (ISO 7, ISO 8) design, workflow, validation & maintenance procedures based Schedule Y CDSCO guidelines.
- Trained in manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Experience in managing Quality aspects of cell manufacturing, Manufacturing and Controls (CMC) sections, including response to regulatory & I EC inquiries.
- Experience in processing Environmental monitoring and in house qualification/validation activities,
- Experience in execution of the necessary Global Operating.
- Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training
- Experience in Designing and optimizing validation tools for Stability testing, Release criteria Testing and Quality Testing.
- Experience in handling Leukapharesis Protocols & Cryopreservation of cellular immunotherapy products.
- Experience in maintenance of Batch record in line with GMP requirements.
- Experience in Developing, reviewing and managing amendments to protocol, patient information sheet and study documentation and timely submit to IEC and Funding agency as per requirement.
Experience is Developing new Clinical Trail protocol with investigators for regulatory and ethics committee submission (ICF,
- IB, CRFs, Study forms) and CTRI registration of trial for new Cell Therapy Products.
DESIRABLE :
- Conceive and develop novel in vitro assays/models to evaluate cell therapy efficacy in the context of the tumor microenvironment.
- Project leadership across multiple projects / roles in a matrixed environment and obtaining alignment across different functional groups to drive decision making
- Anticipate the need for contingencies and demonstrate flexibility through development of alternative strategies
Consolidated Salary : Rs. 67,700/- - Rs. 78,500/- p.m depending on post - PhD experience.
Duration : 6 months and is extendable
Interested Candidates may register for video interview (through zoom) by sending a request email to recruitment@actrec.gov.in mentioning the post applied for, in the subject line.
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