PositionVollzeit · Festanstellung · Director · Ingenieurwesen
Konditionen100%
Anforderungen5+ J. Erfahrung · Master · EU/EFTA-Bewilligung
Deine Übereinstimmung
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Skills
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Scale-up experienceQuality-by-designInterdisciplinary teamworkGxP complianceGlobal Project ManagementQuality control in constructionRisk ManagementQRMCollaboration with software vendorsPharmaceutical developmentExperimental DesignRegulatory submissions
Sprachen
Englisch
Die Stelle
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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
01Lead and manage development, analysis, and production of drug substance for the assigned projects for clinical and / or market supplies
02Lead manufacturing and scale-up activities toward API including supplies of building blocks, Regulatory starting materials or GMP intermediates
03Leads technical transfer for drug substance processes and the definition of CPPs and CMAs for drug substances
04Lead 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
05Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
06Works collaboratively with Drug Product Technical Project Leader(s) to address any physico-chemical requirements for the DS
07Develop and execute risk mitigation plans for drug substance supplies
08Ensure compliance with regulatory guidelines and adapting to and implementation of new regulatory initiatives (e.g. nitrosamines risk assessment) at Idorsia
09Upon project needs at the discretion of the Head of DSDM, assume whole or partial responsibilities and tasks of API safety project leader
Anforderungen
↳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)
Vorteile
Unternehmen
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Idorsia
Biopharmaceuticals
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.
