Lab Specialist MSAT Drug Substance (fmd)

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Lab Specialist MSAT Drug Substance (f/m/d)

Drive innovation and quality in Drug Substance development through a hands-on role independently executing processes acting as a trusted SME and ensuring reliable high-quality outcomes while leveraging digital and AI tools to enhance laboratory efficiency and compliance

How will you contribute:

• Execute Drug Substance development and manufacturing activities at small or commercial scale to support troubleshooting process optimisation and technology transfer activities.
• Act as Subject Matter Expert (SME) for assigned unit operations processes and equipment providing technical expertise and supporting study planning and execution.
• Independently perform hands-on experimental work ensuring accurate execution documentation and timely delivery of high-quality results.
• Make informed decisions during process execution to ensure study success and maintain data integrity.
• Prepare and maintain SOPs safety documentation and other controlled documents within the digital document management system (DMS) utilizing AI tools where applicable.
• Maintain compliant laboratory documentation in electronic systems such as ELN and support the transition toward paperless laboratory processes.
• Lead or support laboratory investigations change controls and continuous improvement initiatives.
• Ensure operational readiness and lifecycle management of assigned laboratory equipment including commissioning calibration maintenance and troubleshooting.
• Coordinate laboratory operations including material procurement stock management and consumables availability.
• Ensure proper maintenance and cleanliness of laboratory and BSL-1 (and potentially BSL-2) areas to support safe and compliant operations.
• Follow laboratory safety procedures and ensure adherence to EHS and regulatory requirements.
• Collaborate effectively with scientists engineers and cross-functional teams and communicate experimental results clearly in English.
• Participate in continuous learning and the adoption of new technologies and scientific approaches.

What you bring to Takeda:

• Completed vocational training in a scientific discipline (e.g. Laboratory Technician MTA BTA CTA) with additional qualification (e.g. Chemietechniker) and/or several years of relevant professional experience in vaccines and/or biologics development or manufacturing environments.
• Strong theoretical and practical experience in mammalian cell culture (adherent and suspension) upstream and downstream processing including purification technologies such as filtration and chromatography.
• Experience working with live viruses and in development or manufacturing-like laboratory environments.
• Knowledge of process scale-up/scale-down and process development activities is advantageous.
• Ability to execute and continuously improve standard operating procedures (SOPs) and experimental protocols with high accuracy.
• Basic understanding of GMP/GLP regulated environments including documentation practices deviation management and data integrity.
• Experience with electronic laboratory systems (e.g. ELN manufacturing execution systems) and basic data analysis tools is a plus.
• Strong attention to detail and accuracy in experimental execution and documentation.
• High level of responsibility for safety quality and compliance.
• Effective team player with the ability to collaborate across MS&T laboratories (Analytical Drug Product and Drug Substance) as well as engineering and other departments.
• Strong problem-solving mindset with a focus on continuous improvement of processes and methods.
• Flexibility and adaptability in a dynamic laboratory environment with changing priorities and project timelines.
• Ability to work in cross-functional and multicultural teams and communicate effectively in English (written and spoken).
• Proactive and curious mindset with interest in new technologies digital tools and laboratory innovation.

About Us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas including gastrointestinal and inflammation rare diseases plasma-derived therapies oncology neuroscience and vaccines.

In Singen around 1200 employees specialize in the production of liquid semi-solid and freeze-dried medicines. Singen is the only production site in the global Takeda network for the manufacture of our new vaccine. Takeda Singen is a regionally significant employer and has been awarded the independent Top Employer certificate several years in a row. The site is characterized by its high level of diversity (e.g. more than 55 nationalities and over 40% of leaders are women) its long company history and its excellent development opportunities. The town of Singen (Hohentwiel) is located on the beautiful Lake Constance in Baden-Württemberg with a view of the Alps and close proximity to France Liechtenstein Austria and Switzerland.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status or any other characteristic protected by law. If you are living with disabilities chronic illness or neurodiversity please feel free to let us know so that we can provide you with appropriate support during the application process.