16 set - Italia
Jobgether
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Drug Product based in Italy.
This is a senior, fully remote leadership opportunity focused on advancing small molecule drug product development across the full development lifecycle. The role will shape formulation, manufacturing, scale-up, technology transfer, validation, and lifecycle strategies across multiple programs. As the drug product subject matter expert, you will provide technical direction while overseeing external development and manufacturing partners. You will work closely with CMC, Quality, Regulatory, Analytical Development, Clinical Supply, and program teams to ensure reliable delivery of high-quality clinical and future commercial supplies. The position combines scientific depth with hands-on execution in a fast-moving, highly outsourced biotechnology environment. It offers significant influence over technical decisions, program strategy, risk management, and manufacturing readiness.
Accountabilities
- Lead drug product CMC strategy and execution for small molecule programs from early clinical development through late-stage development, registration, commercialization, and lifecycle management.
- Direct phase-appropriate formulation and process development for oral solid dosage forms, including formulation selection, optimization, manufacturing process development, scale-up, and control strategy development.
- Provide technical leadership for technology transfers, process characterization, process validation, manufacturing readiness, and related development activities.
- Select, onboard, and provide technical oversight of CDMOs and external partners supporting drug product development, manufacturing, packaging, and associated activities.
- Establish expectations, work plans, timelines, budgets, and performance measures for external partners while ensuring accountability for quality, delivery, and timelines.
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