Associate Director, Technical Project Leader Drug Substance

The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.
Headquartered in Switzerland – a biotech-hub of Europe – Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.

We are looking for a Technical Project Leader – Drug Substance to join our Drug Substance and Sourcing Strategy 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)