About the job
JOB SUMMARY
Iambic Therapeutics is actively seeking a Director of Drug Product Development to spearhead formulation and process development for small molecule programs, guiding them from late discovery/IND-enabling stages through clinical phases, with a clear trajectory towards later-stage development, global registrations, and commercialization. This pivotal role will define the drug product strategy within the CMC framework and drive its execution, supervising scale-up, technology transfer, and manufacturing readiness at Contract Development and Manufacturing Organizations (CDMOs), while ensuring top-tier quality CMC documentation to support global regulatory submissions.
The ideal candidate will possess extensive expertise in formulation design and process development, delivering robust, scalable, patient-centric, and cost-effective drug products throughout various phases of clinical development. This role will collaborate closely with teams across Discovery, Analytical Development, Process Chemistry, Project Management, Quality, Regulatory, Clinical Pharmacology, Clinical Operations, and Supply Chain to synchronize development plans, mitigate risks, and meet program timelines.
This position is based on-site at our San Diego Headquarters.
KEY RESPONSIBILITIES
- Act as the drug product lead in a cross-functional matrix team, defining and executing formulation and manufacturing process strategies in alignment with key stakeholders to achieve program goals.
- Oversee small-molecule formulation design and development from late discovery through clinical stages, converting biopharmaceutic requirements into patient-centric, clinically viable dosage forms that are manufacturable, stable, and compliant with global regulatory standards.
- Collaborate with Chemical Process R&D to enhance Active Pharmaceutical Ingredients (APIs) with optimal physicochemical properties into clinical development.
- Lead process development and optimization using Quality by Design (QbD) principles to establish phase-appropriate control strategies and scalable manufacturing processes.
- Manage CDMO selection and provide comprehensive technical oversight throughout formulation/process development, clinical manufacturing, scale-up, and technology transfer.
- Work with Chemistry, DMPK, and Toxicology teams to evaluate compound developability and establish appropriate nonclinical formulations.
- Draft, review, and approve Module 3 drug product sections for IND/IMPD submissions.
