Senior Director, Biologics CMC Strategy

The Scripps Research Institute; San Diego (CA); Sur place; USD 260 000 - 360 000; Plein temps

Résumé du poste

Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, seeks a Director or Senior Director of Preclinical Development to lead CMC strategy for biologics, focusing on antibodies and ADCs. This senior on-site role requires deep CMC expertise and leadership to guide molecules from lead candidate to IND filing, coordinating with CROs/CDMOs and internal teams.

The candidate will oversee analytical characterization, formulation, and stability for complex formats, ensuring

Qualifications

• PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or a closely related field.
• 10+ years of biologics CMC experience across multi-specific antibody and ADC programs.
• Proven track record advancing biologics from candidate nomination through IND-enabling studies.

Responsabilités

• Define and drive CMC development strategy for biologics programs, including monoclonal and multi-specific antibodies and ADCs.
• Manage external CROs/CDMOs to extend internal capacity, ensuring quality, timelines and budget.
• Own CMC timelines and deliverables across multiple programs through IND submission; author CMC sections for filings.

Connaissances

Biologics CMC

Leadership

Cross-functional collaboration

Regulatory knowledge

Project management

Formation

PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or related field

Outils

Analytical characterization

Description du poste

Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, seeks a Director or Senior Director of Preclinical Development to lead CMC strategy for biologics, focusing on antibodies and ADCs. This senior on-site role requires deep CMC expertise and leadership to guide molecules from lead candidate to IND filing, coordinating with CROs/CDMOs and internal teams.

The candidate will oversee analytical characterization, formulation, and stability for complex formats, ensuring