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Technical Operations Manager (f/m/d)

Singen (Hohentwiel), Germany

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

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  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
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Opportunity

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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    A strong, borderless team, we strive together towards our priorities and inspiring mission.

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    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Technical Operations Manager (f/m/d)

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Job ID R0007985 Date posted 03/28/2019 Location Singen (Hohentwiel), Germany

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Job Description

For English see below.


In External Supply Europa sind wir für das Management und die Lieferung extern hergestellter Takeda Produkte verantwortlich. Höchste Priorität hat dabei die Sicherstellung dass diese Produkte rechtzeitig, in bester Qualität und zu attraktiven Kosten für unsere Kunden auf der ganzen Welt bereitgestellt werden können. Wir sind an der aktiven Auswahl unserer Lohnhersteller sowie der Implementierung und Betreuung neuer Produkte beteiligt. Momentan sind wir in External Supply Europa etwas mehr als 60 Kollegen, die hauptsächlich am Standort in Singen lokalisiert sind.

Ihre Aufgaben:

  • Wissenschaftlich-technischer Kontakt zu Lohnherstellern
  • Verantwortlich für GMP-gerechte Produktion
  • Koordinierung von Änderungsanträgen
  • Pflege und Aktualisierung von regulatorischen Dokumenten
  • Pflege der Dossiers für Nahrungsergänzungsmittel
  • Technische Transfers und Validierungen
  • Risikomanagement
  • Unterstützung bei in- und externen Prozessoptimierungen
  • Interdisziplinäre Berichte und Kooperationen
  • Bereitschaft international zu Reisen (circa 10-15 Arbeitstage pro Jahr)

Ihr Profil:

  • Naturwissenschaftliche Hochschulausbildung (Chemie, Biologie, Pharmazie o.ä.)
  • Minimum drei Jahre Berufserfahrung im GMP-regulierten Bereich (Produktion, QA/QC o.ä.) in der pharmazeutischen Industrie. Alternativ Erfahrung in der Nahrungs- oder Nahrungsergänzungsmittelindustrie
  • Gute Kenntnisse im Bereich Nahrungsergänzungsmittel
  • Erfahrung mit Produkttransfers und Validierungen
  • Erfahrung im Umgang mit Lohnherstellern
  • Organisationstalent und Projektmanagementerfahrung
  • Analytischer Geschäftssinn
  • Gewohnt im internationalen Umfeld zu arbeiten
  • Lösungskompetenz für komplexe Situationen
  • Deutsche Sprachkenntnisse
  • Verhandlungssicheres Englisch

Aufgrund einer Elternzeitvertretung ist die Stelle momentan bis zum 30.09.2020 befristet.

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In External Supply Europe we are responsible for managing and supplying externally manufactured products. Our most important objectives are to ensure that these products are delivered on time, in the right quality and at competitive prices to our affiliates around the world. We participate actively in CMO selection, support implementation and perform CMO management during the product lifecycle. Currently we are more than 60 colleagues in External Supply Europe mainly based in Singen, Germany.

What is the job about?

  • Scientific and technical contact to third party management
  • Responsible for GMP compliant production
  • Coordinate change control activities
  • Maintenance of Module 3 CMC documentation
  • Support update of Food Supplement dossiers
  • Technical transfers and validation activities
  • Risk Management
  • Support process optimisation towards the external manufacturers and within department
  • Support interdisciplinary working/reporting and interdepartmental cooperation
  • Annual travel activity is expected to be approximately 10 –15 days

The preferred candidate has/is:

  • Degree in Sciences (Chemistry, Biology, Pharmaceutics or equivalent)
  • Minimum three years of experience in a GMP regulated environment in production, QA/QC or similar within the pharmaceutical industry. Alternatively in the food or food supplement industry
  • Good knowledge about Food Supplements and legislation
  • Product transfer and validation experience
  • Very good collaboration skills with contract manufacturing organisations
  • Organizational and project management skills
  • Business oriented and with analytical skills
  • Good collaboration and coordination skills
  • Ability to work in a transnational organization
  • Able to solve complex situations and problems
  • German language skills
  • Fluent in English, written and orally

Due to parental leave representation, the position is initially limited to 30.09.2020.

Locations

Singen, Germany

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Job ID R0007985

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