Associate Director, Technical Project Leader Drug Substance

Associate Director, Technical Project Leader Drug Substance

Idorsia Pharmaceuticals

Basel, Switzerland

We are looking for a Technical Project Leader – Drug Substance to join our Drug Substance Development & Manufacturing (DSDM) team to lead the development of new chemical entities with a focus on Drug Substance matters. Idorsia is currently running development programs for numerous products at all clinical phases (I, II & III) as well as managing commercial assets.

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.

Candidate's Requirement

• Chemist, Chemical engineer or equivalent with Master or PhD (preferred) with minimum 5 years of relevant experience in the pharmaceutical industry;
• Minimum of 2 years of leading of an interdisciplinary drug product team;
• Scientific expertise in Drug Substance development and/or Manufacturing;
• Experience in setting development and regulatory drug substances strategies for products in development;
• Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines;
• Profound knowledge in QbD, DOE and QRM;
• Ability to negotiate, plan, and coordinate technical development and manufacturing activities;
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics;
• Excellent English required (oral and written).