Job Opening in Biotech (R&D) – Ahmedabad Location

• Design, perform and review HPLC\UPLC, structural and mass spectrometry based experiments

• Development, qualification of analytical methods and technology transfer

• Preparation of STP, SOP and TTD documentation

• Perform routine calibration of instruments

• Maintain the routine (day-to-day) compliance of the laboratory

• Sample management including procurement of materials required for lab activities

• Technology transfer document preparation – Cross functional with manufacturing team, R&D QA and GMP QA
• Preparation of BMR, MFR and BPR – Cross functional with manufacturing team, GMP-QA and Packaging team
• Packaging development for late phase batches – Clinical trial batches and Commercial process Validation batches as required
• Working with marketing and packaging team on art-work development for primary and secondary labeling
• Working closely with GDSO team for procurement of container-closure system, accessories and manufacturing equipments for late phase batches – Clinical trial batches and Process Validation Batches
• CMC studies (filter selection, filter validation, hold-time studies etc.) for drug product late phase development at R&D to enable successful technology transfer of the manufacturing process
• Formulation development – Identification of CPP, DoE studies after early identification of the formulation
• Working with external labs for extractable and leachable studies for process parts and container-closure system – drug substance and drug product
• Early stage development - execution of formulation screening studies, selection of container-closure systems
• Execution of in-process analysis during formulation screening studies
• Stability / degradation studies – developmental and ICH studies
• Documentation – Formulation development report, Product development report etc.

• Stability study management, protocol design and report writing as per the regulatory requirements.
• Technology transfer to manufacturing plant for drug product scale up batches / exhibit batches / clinical trial batches

Cell and Gene Therapy (CGT) R&D and Manufacturing:

• Conducting upstream and downstream processes for lentivirus production.
• Preparing media and reagents.

• Performing transient and stable transfections for lentivirus generation.
• Optimizing processes to achieve high titers.
• Scaling up production in cell factories or bioreactors.
• Purifying and concentrating lentivirus using tangential flow/diafiltration and chromatography methods.
• Recording data and preparing regulatory documents.

• Executing CAR-T cell production at lab scale and/or with automated/semi-automated systems.
• Preparing media and reagents.
• Handling human blood and cells.
• Isolating immune cells (PBMCs/T cells) from blood.
• Transducing cells with lentivirus.
• Expanding cells, formulating them, and cryopreserving.
• Reviving and maintaining cells.
• Recording data and preparing regulatory documents.
• 
  Quality Control:

• Performing in-process quality control (IPQC) and release tests for CAR-T and lentivirus
• Preparing media and reagents.
• Conducting FACS-based analyses for cell characterization.
• Performing molecular biology assays (RT-PCR/qPCR, agarose gel electrophoresis, DNA sequencing) for characterizing lentivirus and CAR-T cells.
• Conducting cell-based assays for potency testing.
• Performing immunoassays for cytokine profiling.
• Validation/qualification of methods
• Recording data and preparing regulatory documents.