Director or Senior Director, CMC Protein Biologics

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 BiologicsPOSITION 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 LeadershipDefine and drive CMC development strategy for biologics programs, specifically monoclonal antibodies, bispecific/multi-specific antibodies, and antibody-drug conjugatesProvide guidance on format optimization as it relates to antibody architecture and characterization, specifically as they intersect with manufacturability and developabilityMaintain 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 activitiesServe as the internal technical authority on analytical characterization, formulation, and stability considerations unique to multi-specific and conjugated biologic formatsCRO/CDMO ManagementSelect, qualify, and manage external biologics CROs and CDMOs to extend the Institute's internal capacity for protein production, process development, and analytical characterizationImplement and oversee outsourced production and characterization work that complements internal resourcing, ensuring quality, timelines, and budget stay on trackServe 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 manufacturingNegotiate scopes of work, oversee technology transfer, and troubleshoot CMC issues arising from outsourced workProgram & Portfolio ExecutionOwn CMC timelines and deliverables across multiple concurrent biologics programs, from lead candidate through IND submissionAuthor or oversee authoring of CMC sections for IND/CTA filingsPartner cross-functionally with discovery, translational sciences, regulatory, and program leadership to align CMC plans with overall program milestonesIdentify 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 field10+ years of experience in biologics CMC, with direct, hands-on experience across multi-specific antibody and antibody-drug conjugate programsDemonstrated success advancing biologics, including complex antibody formats, from candidate nomination through IND-enabling studies and filingExtensive hands-on and leadership experience in protein expression, purification, and analytical characterization of antibody-based biologics, including multi-specific and conjugated formatsProven ability to lead multidisciplinary CMC teams and manage complex biologics programs in a fast-paced R&D environmentStrong working knowledge of GMP regulations and ICH Q5/Q6/Q7/Q8-Q11 guidelines as applied to biologics CMCStrong understanding of regulatory expectations for CMC sections of IND/CTA submissionsProven experience managing multiple biologics CROs/CDMOs and outsourced protein production and characterization programsExcellent scientific judgment, communication skills, and ability to influence across functionsPrior experience in a senior leadership role strongly preferredThis position requires full-time, on-site presence at Calibr-SkaggsAbility to lead, inspire, and manage a growing CMC function while maintaining hands-on scientific engagementPHYSICAL REQUIREMENTS:May include: Stationary position for an extended period of time, traverse campus/facility as needed, operate machinery such as computer, phone, copy machine; exposure to cold or hot temperatures.COMPENSATION:The expected hiring range for this position is $200,000 TO $275,000 per year, commensurate with experience. Consideration will be given to experience that exceeds the listed requirements.COMPREHENSIVE BENEFITS INCLUDE:Eligible for both ShortTerm (STIP) and LongTerm (LTIP) Incentive Bonus programs, offering a highly competitive total rewards package.Employer Contributed Retirement Plan – Depending on eligibility, employees receive an employer contributed retirement plan (no employee contribution required) and the option to contribute to a 403(b) (which is similar to a 401(k) using your own pre or post-tax dollars)Full Suite of Health and Welfare plans including three medical plan options (including an HSA available option), dental, vision, life insurance, disability, EAP and moreAccess to Flexible Spending Accounts (Medical/Dependent Care)Competitive vacation and sick leave policiesFree, on-site parkingThe above statements describe the level of work performed and expected in general terms. The statements are not intended to list all the responsibilities, duties and/or skills required of employees so classified, and the content herein is subject to change due to the business needs of TSRI, with or without notice. Furthermore, nothing in this job description shall be interpreted to be in conflict with or to eliminate or modify in any way the employment-at-will status of TSRI staff.EEO Statement:The Scripps Research Institute is an Equal Opportunity Employer. We promote diversity of thought, culture and background in the fields of science. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic or status. Job SummaryRequisition Number: DIREC005313Job Category: Scientific StaffSchedule: Full-Time