Associate Director, Technical Project Leader Drug Substance — Idorsia Pharmaceuticals

NewCHF 85'500 - 129'500
Idorsia Pharmaceuticals · Basel (BS)
Categoria: Tecnica Contratto: full-time Salario: CHF 85'500 - 129'500
Apply now
Location
Basel
Contract
full-time
Posted
Yesterday
SalaryCHF 85'500 - 129'500

Role overview

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.

Main responsibilities

  • 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

Application process

  • now Find similar jobs: R&D Functions Technical Support
  • Apply now
Logo Idorsia Pharmaceuticals
Company
Idorsia Pharmaceuticals · Basel
Frontaliere Ticino discovered this opportunity through company monitoring.

All Idorsia Pharmaceuticals jobs in Basel →

Related jobs

Articles for cross-border workers

Explore similar jobs

All jobs in Restaurants →