Job
Description
In this role at ZRC BIOTECH, you will be responsible for various tasks within different groups as outlined below: **Analytical Group:** - Design, perform, and review HPLC\UPLC, structural, and mass spectrometry based experiments. - Develop, qualify analytical methods, and transfer technology. - Prepare STP, SOP, and TTD documentation. - Perform routine calibration of instruments. - Maintain day-to-day compliance of the laboratory. - Manage samples including procurement of materials required for lab activities. **Formulation Development Group:** - Prepare technology transfer documents and collaborate cross-functionally with different teams. - Develop packaging for late phase batches, clinical trial batches, and commercial process validation batches. - Work on art-work development for primary and secondary labeling. - Coordinate with the GDSO team for procurement of equipment and accessories. - Conduct CMC studies for drug product late phase development. - Execute formulation screening studies, stability/degradation studies, and DoE studies. - Manage documentation, stability studies, and protocol design. **Cell and Gene Therapy (CGT) R&D and Manufacturing:** - Qualifications/Experience required: PhD, M. Tech, or M.Sc in Life Sciences, Biochemistry, Biotechnology, or Microbiology. Freshers or candidates with 2-8 years of experience in Cell and Gene Therapy (CGT). - Lentiviral vector manufacturing process development: - Conduct upstream and downstream processes for lentivirus production. - Prepare media and reagents. - Generation of cell banks, reviving, and maintaining mammalian cell lines. - Perform transient and stable transfections for lentivirus generation. - Optimize processes, scale up production, and purify lentivirus. - Record data and prepare regulatory documents. **CAR-T (Chimeric Antigen Receptor T cell) Manufacturing:** - Execute CAR-T cell production at lab scale or with automated/semi-automated systems. - Prepare media and reagents, handle human blood and cells. - Isolate immune cells, transduce cells with lentivirus, and expand cells. - Conduct in-process quality control and release tests. - Perform FACS-based analyses, molecular biology assays, cell-based assays, and immunoassays for potency testing. - Validate/qualify methods and prepare regulatory documents. You should have a background in Life Sciences, Biochemistry, Biotechnology, or Microbiology with either a PhD, M. Tech, or M.Sc degree. Experience in Cell and Gene Therapy (CGT) ranging from freshers to candidates with 2-8 years of experience is preferred for this role.,