Associate Director, Technical Project Leader Drug Product

Idorsia seeks an Associate Director to lead drug product development for oral solid dosage forms in Basel. The role requires extensive experience in pharmaceutical formulation and team leadership.

This position involves joining the Drug Product and CMC strategy team to oversee the development of drug products. The company manages development programs for various oral products across clinical phases I, II, and III, as well as commercial assets, requiring strong technical leadership to ensure successful project execution.

Responsibilities

• Direct the technical development of oral solid dosage forms from early stages through late-phase activities, including formulation work and production scale-up with external partners.
• Manage the development, analysis, and production of solid dosage forms, covering both clinical and market-ready versions.
• Oversee technical drug product development activities, whether conducted in-house or with external vendors, by planning and organizing all aspects required for development, scale-up, validation, and manufacturing up to commercial supply.
• Collaborate with external development partners, emphasizing cost efficiency, adherence to timelines, and scientific quality.
• Support the creation, communication, and execution of the overall CMC strategy.
• Serve as the Subject Matter Expert for drug product manufacturing, focusing on technologies relevant to selected development programs.
• Ensure timely and sufficient supplies for development projects by coordinating with CMC, Project, Life Cycle management, and Global Supply Chain functions.
• Maintain compliance with all relevant regulatory guidelines throughout the development process.

Requirements

• Pharmacist degree or equivalent with a PhD.
• At least 10 years of relevant working experience in the pharmaceutical industry.
• Minimum of 5 years leading interdisciplinary drug product teams.
• Scientific expertise in small molecule formulation development.
• Deep knowledge of GMP, quality control, and pharmaceutical development or production processes based on current guidelines.
• Strong understanding of QbD, DOE, and QRM.
• Excellent oral and written English skills.

Nice to have

• Experience in Lipid Based Formulations and/or Amorphous Solid Dispersions.

About the company

Idorsia harnesses the power of difference, authenticity, and inclusion to achieve business success.

• The company values difference, authenticity, and inclusion to drive business success.