Director or Senior Director, CMC Protein Biologics
About The Position
Calibr-Skaggs Institute for Innovative Medicines, a division of Scripps Research, is seeking a Director or Senior Director of Preclinical Development to lead Chemistry, Manufacturing, and Controls (CMC) strategy for its biologics portfolio, focusing on next-generation antibody formats like multi-specific antibodies and antibody-drug conjugates (ADCs). This leadership role will guide molecules from lead candidate through IND filing, managing external CROs and CDMOs due to the Institute's lean internal structure. The ideal candidate will possess deep scientific expertise in protein CMC, strong people leadership skills, and a proven track record in managing outsourced relationships to advance complex antibody formats. This is a senior, on-site leadership position responsible for guiding CMC strategy and technical execution across multiple biologics programs.
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.
- This position requires full-time, on-site presence at Calibr-Skaggs.
- Ability to lead, inspire, and manage a growing CMC function while maintaining hands-on scientific engagement.
Nice To Haves
- Prior experience in a senior leadership role strongly preferred.
Responsibilities
- 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.
- 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.
- 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., heteridimerization, chain mispairing, aggregation, linker/payload stability).
Benefits
- Eligible for both Short-Term (STIP) and Long-Term (LTIP) Incentive Bonus programs
- Employer Contributed Retirement Plan
- 403(b) option
- Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and more
- Access to Flexible Spending Accounts (Medical/Dependent Care)
- Competitive vacation and sick leave policies
- Free, on-site parking
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
