Job Description

Sub Department
ZRC BIOTECH
Job posted on
Aug 23, 2025
Employee Type
C-C5-Confirmed-R&D Staff
Experience range (Years)
3 years - 13 years

Analytical Group :

Design, perform and review HPLCUPLC, 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:

Qualifications/Experience

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 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.