Job Responsibilities

The Technical Project Leader Drug Substance will lead the technical development of several drug substances, from early phase to late phase development activities up to commercial and/or product discontinuation. Main responsibilities are as follows:

• Lead and manage development, analysis, and production of drug substance for the assigned projects for clinical and / or market supplies
• Lead manufacturing and scale-up activities toward API including supplies of building blocks, Regulatory starting materials or GMP intermediates
• Leads technical transfer for drug substance processes and the definition of CPPs and CMAs for drug substances
• Lead the technical drug substance development activities (in house or external): plan, organize and administer the different aspects of the technical activities required for development, scale-up, validation and manufacturing of a drug from development up to commercial supplies
• Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
• Works collaboratively with Drug Product Technical Project Leader(s) to address any physico-chemical requirements for the DS
• Develop and execute risk mitigation plans for drug substance supplies
• Ensure compliance with regulatory guidelines and adapting to and implementation of new regulatory initiatives (e.g. nitrosamines risk assessment) at Idorsia
• Upon project needs at the discretion of the Head of DSDM, assume whole or partial responsibilities and tasks of API safety project leader