Director, Pharmaceutical Development
Core
Lead small molecule drug product development for oral and topical dosage forms from early phase through commercial launch, managing QbD-based formulation, process development, and CDMO partnerships.
Role type
Director, Pharmaceutical Development
Builds
Small molecule drug products (oral/topical) for cancer and inflammatory disease treatments
Domain
Biopharmaceuticals / Targeted protein degradation
Required skills
QbD formulation and process development, BCS Class II/IV compound development, amorphous solid dispersions, lipid-based drug delivery systems, nano-formulations, QTPP definition, CQA/CMA/CPP risk assessment, manufacturing scale-up, CMC regulatory submissions, CDMO management, late-stage development (Phase 2b/3), GMP compliance, team leadership
Preferred skills
Ph.D. in Pharmaceutical Sciences/Chemistry/Chemical Engineering, strategic planning, budget ownership
Technologies
spray-dried dispersions, hot-melt extrusion, SMEDDS, SEDDS, lipid suspensions
Responsibilities
Lead QbD-based formulation and process development for oral and topical dosage forms; Define QTPP and identify CQAs; Conduct risk assessments using FMEA; Lead manufacturing scale-up from lab to commercial; Troubleshoot manufacturing deviations; Drive late-stage development including PPQ and CPV; Author and review CMC sections of regulatory submissions; Manage external CDMO partnerships and vendor qualification; Provide scientific leadership and mentorship to junior scientists
Seniority
Director, strategic planning and team leadership