Director, Drug Product Development

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.

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

Benefits

• Industry leading competitive pay
• Company paid healthcare
• Flexible spending accounts
• Voluntary life insurance
• 401K matching
• Uncapped vacation