Senior ADC CMC & Regulatory Consultant

DSI - Design Space InPharmatics LLC; Miami (FL); On-site; USD 100,000 - 130,000; Full time

Job summary

DSI - Design Space InPharmatics LLC is looking for an ADC Scientist Consultant to lead the CMC strategy for ADC molecules, providing technical and regulatory expertise from early development through market authorization.

The ideal candidate will have deep knowledge of cell lines, linkers, and payloads, as well as the ability to manage CDMO partnerships. This role offers the opportunity to shape CMC strategies and troubleshoot technical issues in high-impact settings.

Qualifications

• Experience with ADC CMC lifecycle and development.
• Ability to manage CDMO relationships effectively.
• Strong strategic and regulatory fluency.

Responsibilities

• Design overall CMC strategy for ADC molecules.
• Manage day-to-day CDMO relationships and performance.
• Prepare CMC sections of regulatory submissions.

Skills

ADC Technical Expertise

Cell line development and selection

Linker chemistries knowledge

Cytotoxic payloads understanding

Job description

DSI - Design Space InPharmatics LLC is looking for an ADC Scientist Consultant to lead the CMC strategy for ADC molecules, providing technical and regulatory expertise from early development through market authorization.

The ideal candidate will have deep knowledge of cell lines, linkers, and payloads, as well as the ability to manage CDMO partnerships. This role offers the opportunity to shape CMC strategies and troubleshoot technical issues in high-impact settings.