TA
Takeda Manufacturing Austria AG8 Tage
Associate Director, API Process Engineering(m/w/x)
Management
Vollzeit
Keine Angabe
Zürich, Neuenburg, Oranienburg
Nejo KI-Zusammenfassung
In this role, you will be the go-to expert for small-molecule API manufacturing, leading efforts from process design to validation. Your work will involve enhancing process understanding, driving continuous improvement, and collaborating with various teams to ensure compliance and efficiency.
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Anforderungen
- •Master's degree in Chemical, Process, or Pharmaceutical Engineering
- •At least 5 years of experience in cGMP manufacturing
- •At least 5 years of pharmaceutical industry experience in small-molecule APIs
- •Strong foundation in organic/pharmaceutical chemistry and chemical engineering
- •In-depth understanding of pharmaceutical manufacturing processes and ICH guidelines
- •Experience in mechanistic modelling, process simulation, and data-driven optimization
- •Proven track record in API process characterization and technology transfer
- •Strong problem-solving, project management, and stakeholder management skills
- •Excellent written and verbal communication skills
- •Ability to work independently and collaboratively in multi-disciplinary teams
- •Commitment to sharing knowledge and building technical capabilities
- •Intellectual curiosity about technology and new ways of working
- •Willingness to travel to international manufacturing sites
Master-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Lead small molecules API manufacturing sciences activities
- •Provide process engineering support for batch and continuous API platforms
- •Apply mechanistic modelling and process simulation to enhance process understanding
- •Conduct API manufacturing process characterization and risk assessments
- •Define critical process parameters and controls
- •Oversee technology transfer of API processes between internal sites and external CMOs
- •Lead API process validation activities, including strategy and protocol design
- •Support execution and data evaluation for process validation
- •Develop strategies for continuous improvement of marketed API processes
- •Optimize yield and improve robustness while reducing cost of goods
- •Establish systems for best practices in technology transfer and process validation
- •Build and maintain a central knowledge base of API processes
- •Collaborate with GMS functions and site leadership
- •Provide technical support for marketing applications in global markets
- •Prepare responses to regulatory questions from health authorities
- •Utilize root cause analysis to investigate process and equipment issues
- •Deliver sustainable corrective and preventive actions
- •Provide subject matter expertise for due diligence in mergers and acquisitions
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Takeda Manufacturing Austria AG 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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