Job Opening in Biotech

Department
- ZRC BIOTECH
- Job posted on
- Aug 23, 2025
- Employment type
- C-C5-Confirmed-R&D Staff

**Analytical Group**:

- 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

**Formulation Development Group**
- 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**:
**Lentiviral vector mfg process development**:

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

Generation of cell banks, reviving and maintenance of various mammalian cell lines.
- 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.

**CAR-T (Chimeric Antigen Receptor T cell) Manufacturing**:

- 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.