Director or Senior Director, CMC Protein Biologics

Scripps Research; Mountain House (CA); Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, seeks a Director/Senior Director of Preclinical Development to lead CMC strategy for our biologics portfolio. This on-site leadership role oversees CROs/CDMOs, IND-enabling activities, and cross-functional alignment with discovery and regulatory teams.

The ideal candidate has deep CMC expertise, 10+ years in biologics, and a proven track record delivering complex antibody formats from candidate through IND filing

Qualifications

• PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or related field.
• 10+ years of biologics CMC experience with multi-specific antibodies and ADCs.
• Experience leading CMC teams and IND-enabling studies.
• Experience managing CROs/CDMOs and outsourced programs.
• Strong GMP/ICH knowledge and regulatory experience.
• On-site, full-time leadership role.

Responsabilités

• Define and drive CMC development strategy for biologics programs, focusing on monoclonal antibodies and antibody-drug conjugates.
• Manage external CROs/CDMOs to extend internal capacity and ensure quality, timelines, and budget.
• Own CMC timelines and deliverables from lead candidate to IND submission.
• Collaborate with discovery, regulatory, and program leadership to align CMC plans with milestones.

Connaissances

Biologics CMC

Outsourced CRO/CDMO mgmt

IND filings

Leadership

Formation

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

Description du poste

Job Details

Posting Details

• • Posted on October 13, 2026

Locations

Showing 1 location CA Campus
San Diego, CA, USA

• Scientific Staff
• Full-Time
• Requisition #: DIREC005313

Description

ABOUT US :

Calibr-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. Calibr-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, Calibr-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. Calibr-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.

POSITION TITLE : Director or Senior Director, CMC Protein Biologics

POSITION SUMMARY :

Calibr-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.

RESPONSIBILITIES AND DUTIES:

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 developability
• Maintain working command of what it takes to develop an antibody as a drug: developability 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)

POSITION REQUIREMENTS :

• PhD. in Biochemistry, Chemistry, Molecular/Cell Biology, or a closely related field
• 10+ years of experience in biologics CMC, with direct, hands-on experience across multi-specific antibody and antibody-drug conjugate programs
• Demonstrated success advancing biologics, including complex antibody formats, from candidate nomination through IND-enabling studies and filing
• Extensive hands-on and leadership experience in protein expression, purification, and analytical characterization of antibody-based biologics, including multi-specific and conjugated formats
• Proven ability to lead multidisciplinary CMC teams and manage complex biologics programs in a fast-paced R&D environment
• Strong working knowledge of GMP regulations and ICH Q5/Q6/Q7/Q8-Q11 guidelines as applied to biologics CMC
• Strong understanding of regulatory expectations for CMC sections of IND/CTA submissions
• Proven experience managing multiple biologics CROs/CDMOs and outsourced protein production and characterization programs
• Excellent scientific judgment, communication skills, and ability to influence across functions
• Prior experience in a senior leadership role strongly preferred
• This position requires full‑time, on-site presence at