Director or Senior Director, CMC Protein Biologics

Scripps Research•San Diego, CA

2d•Onsite

About The Position

Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is seeking a Director or Senior Director to lead Chemistry, Manufacturing, and Controls (CMC) strategy for its biologics portfolio, particularly next-generation antibody formats such as multi-specific antibodies and antibody-drug conjugates (ADCs). The role guides molecules from lead candidate through IND filing and provides senior leadership for CMC strategy and technical execution across multiple biologics programs. Because the Institute has a lean internal structure, the position relies on a network of external CROs and CDMOs while maintaining close collaboration with internal discovery, translational sciences, regulatory, and program teams. The successful candidate will bring deep protein CMC expertise, people leadership, and experience managing outsourced CRO/CDMO relationships. This is a full-time, on-site leadership role that combines strategic direction with hands-on scientific engagement and responsibility for advancing complex antibody formats.

Requirements

PhD in Biochemistry, Chemistry, Molecular/Cell Biology, or a closely related field.
10+ years of experience in biologics CMC, including direct, hands-on experience with 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 and communication skills, with the ability to influence across functions.
Ability to work full-time on site at Calibr-Skaggs.

Nice To Haves

Prior experience in a senior leadership role.

Responsibilities

Define and drive CMC development strategy for biologics programs, including monoclonal antibodies, bispecific and multi-specific antibodies, and antibody-drug conjugates.
Guide format optimization involving antibody architecture and characterization, particularly with respect to manufacturability and developability.
Provide expertise in antibody developability assessment, candidate selection criteria, and transition from discovery into CMC/process development and IND-enabling activities.
Serve as the internal technical authority on analytical characterization, formulation, and stability considerations for multi-specific and conjugated biologics.
Select, qualify, and manage external biologics CROs and CDMOs supporting protein production, process development, and analytical characterization.
Oversee outsourced production and characterization work to ensure quality, timelines, and budgets remain on track.
Act as the primary interface between internal discovery and translational teams and external manufacturing and analytical partners.
Negotiate scopes of work, oversee technology transfer, and troubleshoot CMC issues arising from outsourced work.
Own CMC timelines and deliverables across multiple biologics programs from lead candidate through IND submission.
Author or oversee the authoring of CMC sections for IND/CTA filings.
Partner with discovery, translational sciences, regulatory, and program leadership to align CMC plans with program milestones.
Identify and mitigate CMC risks associated with complex formats, including heterodimerization, chain mispairing, aggregation, and linker/payload stability.
Lead, inspire, and manage a growing CMC function while maintaining hands-on scientific engagement.

Benefits

Eligibility for Short-Term Incentive Program (STIP) and Long-Term Incentive Program (LTIP) bonuses.
Employer-contributed retirement plan, subject to eligibility, with no employee contribution required.
Option to contribute to a 403(b) plan.
Three medical plan options, including an HSA-available option.
Dental insurance.
Vision insurance.
Life insurance.
Disability coverage.
Employee assistance program (EAP).
Flexible Spending Accounts for medical and dependent care.
Competitive vacation and sick leave policies.
Free on-site parking.