Key Responsibilities:

• Lead ADC development activities from early-stage feasibility and molecule assessment through process optimization, characterization and technology transfer.

• Plan and oversee antibody selection/assessment, linker-payload compatibility studies, conjugation strategy and conjugation process development.

• Develop and optimize conjugation parameters such as reaction conditions, pH, temperature, molar ratios, reaction time, quenching and purification.

• Drive control of critical quality attributes (CQAs), including drug-to-antibody ratio (DAR), conjugation-site distribution, aggregation, free drug, residual solvents and product heterogeneity.

• Work closely with analytical development teams on characterization using suitable techniques such as HIC, SEC, RP-HPLC, LC-MS, CE-SDS, UV/Vis and potency/binding assays.

• Guide purification and downstream process development, including TFF, chromatography and other fit-for-purpose unit operations, as applicable.

• Establish process parameters,



in-process controls, acceptance criteria and process characterization strategies; support risk assessments and design-of-experiments (DoE).

• Lead troubleshooting, root-cause investigations and continuous improvement for process- and product-related challenges.

• Coordinate with upstream, downstream, analytical, formulation, quality, regulatory, manufacturing and external partners to meet program milestones.

• Support scale-up, engineering batches, process performance studies and technology transfer from R&D; to pilot/commercial manufacturing.

• Ensure scientific documentation, development reports, protocols, batch records and technical reports are complete, accurate and audit-ready.

• Build and mentor a high-performing ADC development team; manage project timelines, resources and technical deliverables.

📌 Lead- ADC development (biologics) (India)
🏢 Talental Consultings
📍 India