Serve as the drug product lead in a cross-functional matrix team, defining and driving execution of formulation and manufacturing process strategies in alignment with key stakeholders to meet program objectives.
Lead small-molecule formulation design and development from late discovery through clinical stages, translating biopharmaceutic requirements into patient-centric, clinically viable dosage forms that are manufacturable, stable, and compliant with global regulatory expectations.
Partner with Chemical Process R&D on the DS-DP interface to advance APIs with optimal physicochemical properties (such as solid form, PSD/morphology, pH-solubility, and stability) into clinical development.
Drive process development, characterization and optimization using Quality by Design (QbD) principles such as risk assessments, DoE, and statistical analysis to define phase-appropriate control strategies and scalable manufacturing processes.
Lead CDMO selection, management, and end-to-end technical oversight across formulation/process development, and through clinical manufacturing, scale-up, and tech transfer.
Partner with Chemistry, DMPK and Toxicology teams to assess compound developability and to define fit-for-purpose nonclinical formulations.
Author, review, and approve Module 3 drug product sections for IND/IMPD submissions through global marketing applications (e.g. NDA/MAA), including responses to health authority queries.
Maintain up-to-date scientific knowledge and leverage industry benchmarking insights to design product development strategies.
Manage budget proposals and contribute to the annual budgeting of CMC.
Requirements
Ph.D. in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering (or related field) with 10+ years industry experience; M.S. with 12+ years; or B.S. with 15+ years of relevant experience.
Deep expertise in small-molecule early and late-stage drug product development, including formulation design, process development, scale-up, and tech transfer for oral solid dosage (OSD) forms.
Strong hands-on and oversight experience in OSD unit operations (blending, granulation, compression, coating) and phase-appropriate control strategies using QbD elements.
Extensive experience with enabling formulation technologies (e.g., ASD via spray drying or hot melt extrusion, lipid-based systems, and nano-milling).
Proven success managing CDMOs to develop formulations and processes and deliver clinical supply on aggressive timelines.
Demonstrated ability to work effectively in diverse, cross-functional teams and excel in a fast-paced environment while managing multiple priorities.
Expert in troubleshooting formulation, process, and manufacturing challenges using fundamentals of pharmaceutics, physical chemistry, and materials science.
Extensive track record of drug product Module 3 submissions for IND/IMPD through NDA/MAA, including responses to health authority questions.
In-depth knowledge of GLP, cGMP, ICH, worldwide regulatory requirements, and current industry best practices for drug product.
Strong external scientific presence and a track record of building trusted networks with vendors.
Excellent written and verbal communication skills, including technical writing and clear communication with senior stakeholders.
Ability to travel up to 30% domestically and internationally.
ABOUT IAMBIC THERAPEUTICS
Benefits
Health insurance
Additional Information
JOB SUMMARY
Iambic Therapeutics is seeking a Director , Drug Product Development to lead formulation and process development for small molecule programs from late discovery/IND-enabling through clinical phases, with a clear path to later-stage development, global registrations, and commercialization. This role will set drug product strategy within CMC and drive execution, oversee scale-up, technology transfer, and manufacturing readiness at CDMOs, and ensure high-quality CMC documentation to support global regulatory filings.
The successful candidate brings deep subject matter expertise in formulation design and process development to deliver robust, scalable, patient-centric, and cost-effective drug products from early through late phases of clinical development. This role will partner closely with Discovery, Analytical Development, Process Chemistry, Project Management, Quality, Regulatory, Clinical Pharmacology, Clinical Operations, and Supply Chain teams to align development plans, manage risk, and deliver on program timelines.
This position will be on-site at our San Diego Headquarters.
Iambic-therapeutics · San Diego