Director or Senior Director, CMC Protein Biologics

Cali
-Skaggs Institute for Innovative Medicines was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Cali
-Skaggs is a division of Scripps Research, a first-of-its-kind, nonprofit translational research institute dedicated to creating the next generation of medicines. Scripps Research is ranked the most influential institution in the world for its impact on innovation. Our educational and training programs mold talented and committed students and postdocs into leading-edge scientists. Leveraging the unique scientific environment of Scripps Research, impacting translational sciences, Cali
-Skaggs has created a portfolio of drug candidates, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while reinvesting in further innovative research. We expand basic knowledge in the biosciences and use these fundamental advancements to develop profound innovations that improve wellbeing. Cali
-Skaggs’ drug development portfolio spans a broad range of human diseases, including cancer, autoimmunity and inflammatory diseases, metabolic and cardiovascular diseases, infectious and neglected tropical diseases, as well as age-related and degenerative diseases. If you have a passion for making a difference, this could be your opportunity to join our transformative team.

Director or Senior Director, CMC Protein Biologics

Cali
-Skaggs is seeking a Director or Senior Director of Preclinical Development to lead Chemistry, Manufacturing, and Controls (CMC) strategy for our biologics portfolio, with a particular focus on next-generation antibody formats — multi-specific antibodies and antibody-drug conjugates (ADCs). This individual will play a critical leadership role in guiding molecules from lead candidate through IND filing, working across a network of external CROs and CDMOs given the Institute's lean internal structure.

The successful candidate will bring deep scientific expertise in protein CMC, strong people leadership, and a proven track record managing outsourced CRO/CDMO relationships to advance complex antibody formats. This is a senior, on-site leadership role responsible for guiding CMC strategy and technical execution across multiple biologics programs.

CMC Strategy & Technical Leadership

• Define and drive CMC development strategy for biologics programs, specifically monoclonal antibodies, bispecific/multi-specific antibodies, and antibody-drug conjugates
• Provide guidance on format optimization as it relates to antibody architecture and characterization, specifically as they intersect with manufacturability and develop ability
• Maintain working command of what it takes to develop an antibody as a drug: develop ability assessment, candidate selection criteria, and the handoff from discovery into CMC/process development and IND-enabling activities
• Serve as the internal technical authority on analytical characterization, formulation, and stability considerations unique to multi-specific and conjugated biologic formats

CRO/CDMO Management

• Select, qualify, and manage external biologics CROs and CDMOs to extend the Institute's internal capacity for protein production, process development, and analytical characterization
• Implement and oversee outsourced production and characterization work that complements internal resourcing, ensuring quality, timelines, and budget stay on track
• Serve as the primary interface between internal discovery/translational teams and external manufacturing and analytical partners, enabling seamless progression of molecules into and through candidate nomination, process development, and early manufacturing
• Negotiate scopes of work, oversee technology transfer, and troubleshoot CMC issues arising from outsourced work

Program & Portfolio Execution

• Own CMC timelines and deliverables across multiple concurrent biologics programs, from lead candidate through IND submission
• Author or oversee authoring of CMC sections for IND/CTA filings
• Partner cross-functionally with discovery, translational sciences, regulatory, and program leadership to align CMC plans with overall program milestones
• Identify and mitigate CMC risk points specific to complex formats (e.g., heterodimerization, chain mispairing, aggregation, linker/payload stability)

• PhD. in Biochemistry, Chemistry,…