Idorsia seeks an Associate Director to lead drug substance development and technical project leadership in Basel. This senior role focuses on scaling new chemical entities and managing interdisciplinary teams.
Positioned within the Drug Substance and Sourcing Strategy team, this role drives the development of new chemical entities with a specific emphasis on drug substance matters. The company is a high-potential biopharmaceutical firm dedicated to innovative small molecules, and this position plays a key part in advancing its scientific and manufacturing goals.
Responsibilities
- Oversee the development, analysis, and production of drug substances for designated projects.
- Direct manufacturing and scale-up activities aimed at producing active pharmaceutical ingredients (API).
- Manage technical transfers for drug substance processes and define Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs).
- Plan, organize, and administer technical aspects of drug substance development.
- Collaborate with external development partners to ensure cost efficiency, adherence to timelines, and scientific quality.
- Work closely with Drug Product Technical Project Leaders to address physico-chemical requirements.
- Create and execute risk mitigation plans to secure drug substance supplies.
- Ensure strict compliance with regulatory guidelines and implement new regulatory initiatives.
Requirements
- Chemist, Chemical Engineer, or equivalent qualification with a Master’s or PhD degree.
- At least 5 years of relevant experience in the pharmaceutical industry.
- Minimum of 2 years leading an interdisciplinary drug product team.
- Scientific expertise in drug substance development and/or manufacturing.
- Experience in setting development and regulatory strategies for drug substances.
- Deep knowledge of GMP, quality control, and pharmaceutical development and/or production processes.
- Strong understanding of QbD, DOE, and QRM.
- Excellent English proficiency, both oral and written.
Nice to have
- PhD degree (preferred over Master).
About the company
Idorsia harnesses the power of difference, authenticity, and inclusion to achieve business success. The company is a high-potential biopharmaceutical firm specialized in innovative small molecules.
- The company harnesses the power of difference, authenticity, and inclusion to achieve business success.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.