Kishore Jahagirdar

• CMC lead for clinical stage production of novel biotherapeutic protein in microbial cell-line. Led team process development (upstream and downstream), formulation and manufacturing for completing technology transfer and clinical scale manufacturing at 200 L for clinical studies.

• Led process development, tech transfer & GMP campaign for CHO-based novel bispecific at 1000 L scale, achieving IND approval.

• Established green field 200 L GMP-compliant Drug Substance GMP manufacturing facility, achieving CDSCO & QP approval.

• Led SAP ERP implementation, integrating MM, QM, PP modules to streamline processes and support digital transformation.

• Built GMP warehouse with ERP-based inventory traceability, ensuring GDP compliance. Worked on establishing system for cGMP and R&D inventory management systems.

• Directed equipment qualification (IQ/OQ/PQ, CSV) and authored strategy documents (CCS, PAQs, BOD).

• Managed a team of 16 members to ensure effective task completion and collaboration., managing task distribution, scheduling, training, resource allocation, and performance evaluations to optimize team effectiveness.

• Lead for CMC development of biosimilar mab for clinical phase 1 with team members from cell line, upstream, downstream, formulation, MSAT and manufacturing (DS & DP) functions.

• Delivered clinical material campaigns as downstream lead for fusion proteins & mAbs, ensuring operational stability and consistency.

• Conducted process characterization, virus validation, supported process validation and involved in qualification batches to support BLA filings.

• For biosimilarity assessment for phase 1 product and analytical characterisation of product.

• Directed purification process development across multiple biosimilars mabs at varying stages of development.

• Enabled process intensification strategies to enhance yield by 20% during lifecycle management.

• Part of a team working on vendor qualification.

• Contributed to compilation of process sections for Module 3 dossier submission for biosimilar antibody (metastatic colorectal cancer), resulting in India MAA approval and commercial launch.

• Directed downstream process transfer, facilitating clinical and commercial scale production of biosimilars.

• Supported IND amendment for Phase III trial approval, conducting comparability and virus risk assessments.

• Supported introduction of inventory controls across functions.

• Supported introduction of inventory controls across functions.

• Exposure to Project Management and Supply Chain management as a part of PGDBM course work.

• Redesigned downstream processes, enhancing biosimilarity in mAbs process scaled from 200 L to 1000 L, improving product consistency.
• Supported formulation development and clinical material generation for erythropoietin and two mAb biosimilar products, contributing to successful regulatory submissions.
• Optimized cation exchange and TFF stages, achieving yield improvements of 25–30%.

• Assisted in laboratory experiments to support ongoing research on purification process development of serum proteins for diagnostic kits.