Idorsia
Associate Director, Technical Project Leader Drug Product(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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IDIdorsia
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading drug substance development for innovative small molecules at a biopharmaceutical company specializing in discovery. 5+ years pharmaceutical industry experience and drug substance scientific expertise required. Full lifecycle involvement from early phases to commercialization.
Anforderungen
- Degree in Chemistry, Chemical Engineering, or equivalent
- Minimum 5 years pharmaceutical industry experience
- Minimum 2 years interdisciplinary team leadership
- Scientific expertise in Drug Substance development
- Experience in drug substance regulatory strategies
- Profound knowledge of GMP and QC
- Profound knowledge in QbD, DOE, QRM
- Ability to coordinate technical manufacturing activities
- Excellent interpersonal and adaptation skills
- Excellent oral and written English
Aufgaben
- Lead drug substance development from early phases to commercialization
- Manage production of drug substances for clinical and market supplies
- Oversee manufacturing and scale-up activities for active pharmaceutical ingredients
- Direct technical transfers and define critical process parameters
- Plan and administer technical activities for drug validation
- Coordinate with external partners to ensure cost-efficient scientific quality
- Collaborate with drug product leaders on physico-chemical requirements
- Develop and execute risk mitigation plans for supplies
- Ensure compliance with evolving global regulatory guidelines
- Perform nitrosamine risk assessments and other regulatory initiatives
- Assume API safety project leadership responsibilities as required
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- QbD
- DOE
- QRM
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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IDIdorsia
Associate Director, Technical Project Leader Drug Substance(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading drug substance development for innovative small molecules at a biopharmaceutical company specializing in discovery. 5+ years pharmaceutical industry experience and drug substance scientific expertise required. Full lifecycle involvement from early phases to commercialization.
Anforderungen
- Degree in Chemistry, Chemical Engineering, or equivalent
- Minimum 5 years pharmaceutical industry experience
- Minimum 2 years interdisciplinary team leadership
- Scientific expertise in Drug Substance development
- Experience in drug substance regulatory strategies
- Profound knowledge of GMP and QC
- Profound knowledge in QbD, DOE, QRM
- Ability to coordinate technical manufacturing activities
- Excellent interpersonal and adaptation skills
- Excellent oral and written English
Aufgaben
- Lead drug substance development from early phases to commercialization
- Manage production of drug substances for clinical and market supplies
- Oversee manufacturing and scale-up activities for active pharmaceutical ingredients
- Direct technical transfers and define critical process parameters
- Plan and administer technical activities for drug validation
- Coordinate with external partners to ensure cost-efficient scientific quality
- Collaborate with drug product leaders on physico-chemical requirements
- Develop and execute risk mitigation plans for supplies
- Ensure compliance with evolving global regulatory guidelines
- Perform nitrosamine risk assessments and other regulatory initiatives
- Assume API safety project leadership responsibilities as required
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMP
- QbD
- DOE
- QRM
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Idorsia erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Idorsia
Branche
Pharmaceuticals
Beschreibung
The company is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules.
Noch nicht perfekt?
- Idorsia
Associate Director, Technical Project Leader Drug Product(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Novartis Pharma AG
Director - Technical Project Leader (TPL)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Head Clinical and Commercial Drug Substance Supply(m/w/x)
Vollzeitnur vor OrtManagementBasel - Roche
Head Clinical and Commercial Drug Substance Supply(m/w/x)
Vollzeitnur vor OrtManagementBasel - Novartis Pharma AG
Associate Director Science & Technology(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel