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 Calibr-Skaggs
- Ability to lead, inspire, and manage a growing CMC function while maintaining hands-on scientific engagement
PHYSICAL 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 Short-Term (STIP) and Long-Term (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 more
- Access to Flexible Spending Accounts (Medical/Dependent Care)
- Competitive vacation and sick leave policies
- Free, on-site parking
The 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.
