Director, Drug Product Development
$196k/y-$245k/y
Iambic Therapeutics3 days ago
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OnsiteFull-timeDirector
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.
About the Role
As the Director of Drug Product Development, you will set drug product strategy within CMC, oversee scale-up, technology transfer, and manufacturing readiness at CDMOs, and ensure high-quality CMC documentation to support global regulatory filings. You will collaborate with various teams to align development plans, manage risks, and deliver on program timelines, while leading small-molecule formulation design and development.
About You
Required:
- 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.
Preferred:
- 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.
Benefits
- Industry leading competitive pay.
- Company paid healthcare.
- Flexible spending accounts.
- Voluntary life insurance.
- 401K matching.
- Uncapped vacation.
- State-of-the-art facility in San Diego with an onsite gym and dining.
Iambic Therapeutics
Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai
San Diego, CA