Senior / Principal Scientist, ADC Conjugation Process Development

We are seeking an experienced and motivated Senior/Principal Scientist in ADC Conjugation Process Development to support our growing pipeline.

This role will be responsible for the optimization of critical conjugation and purification process parameters for ADC Drug Substance (DS) Development.

The preferred candidate will coordinate and execute strategies from milligram to multi-gram scales, including tox/GMP batches, while demonstrating practical expertise in different methodologies and purification strategies for clinical and commercial-stage ADC DS manufacturing.

The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities.

A strong working knowledge of different conjugation technologies and cytotoxic linker-payloads is essential, as is experience with standard analytical and characterization approaches used for both biologics and ADCs.

• Implement and execute ADC Conjugation Process Development (PD) strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical reaction parameters.
• Oversee the progression of ADC batch sizes from milligram to >100 g scales to support not only PD optimization, but analytical and formulation development, DS/DP stability studies, and in vivo experiments (including critical GLP tox studies) for both IND- and BLA-stage activities .
• Lead the multi-gram scale purification optimization for both antibody intermediates and ADCs via ultrafiltration/diafiltration (UF/DF), and, if required , preparative chromatography or other approaches.
• Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and for external CDMO partners to ensure alignment on ADC program goals, deliverables, and objectives . Occasional travel to advise and oversee Development and GMP manufacturing processes will be expected.
• Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
• Stay current with emerging trends, innovations, and regulatory requirements for ADC DS, integrating necessary or potentially beneficial features into our internal company strategies and workflows.