Role at a glance
- Job function
-
Engineering & R&D Biotechnology & Pharmaceutical R&D
- Salary
- Not Disclosed
- Location
- Singen, Germany
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- several years of relevant professional experience in sterile manufacturing environments
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Role Summary
The Lab Specialist MSAT Drug Product joins Takeda’s MSAT Drug Product Lab team in Singen and supports innovative vaccine manufacturing. The role focuses on drug product process experiments and technical laboratory operations across formulation, aseptic filling, freeze drying and capping.
What You'll Do
- Plan and execute drug product process experiments, including formulation, aseptic filling, freeze drying and capping
- Act as Subject Matter Expert for assigned process steps and laboratory equipment
- Evaluate, interpret and document experimental results in compliance with GMP, laboratory quality standards and internal procedures
- Lead or support laboratory investigations and change controls, including root-cause identification and corrective actions
- Ensure operational readiness of equipment and systems through qualification, calibration, cleaning and maintenance
- Maintain laboratory operations, controlled documentation, material management and digital-system records
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Completed vocational training in a scientific discipline with further qualification or several years of relevant professional experience in sterile manufacturing environments; hands-on experience in GMP-regulated pharmaceutical manufacturing, pilot-scale or laboratory environments; theoretical understanding of aseptic techniques and basic microbiology; experience operating sterile production and laboratory equipment; experience with SOPs, batch documentation, experimental protocols, DMS, ELN and MS Excel; accuracy, reliability, quality and compliance mindset, structured and independent working approach, safety-conscious behavior, cross-functional teamwork, and willingness to continuously develop technical knowledge.
Required
- Completed vocational training in a scientific discipline with further qualification or several years of relevant professional experience...
- Proven hands-on experience in GMP-regulated pharmaceutical manufacturing, pilot-scale or laboratory environments
- Solid theoretical understanding of aseptic techniques and basic microbiology
- Practical experience operating sterile production and laboratory equipment, including autoclaves, freeze dryers, filling systems,...
- Confident handling of SOPs, batch documentation and experimental protocols in compliance with GMP requirements
- Experience with electronic documentation systems such as DMS and ELN and standard data analysis tools such as MS Excel
- High level of accuracy and reliability in experimental execution and documentation
- Strong quality and compliance mindset with a structured and independent working approach
Preferred
- Experience supporting validation, troubleshooting or technology transfer activities is advantageous
Original job description
Content provided by the employer
Original job description
Content provided by the employer
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Job Description
Lab Specialist MSAT Drug Product (f/m/d)
Join Takeda’s MSAT Drug Product Lab team and help advance innovative vaccine manufacturing—your hands-on DP process expertise makes the difference.
How will you contribute:
- Plan and execute experiments for the drug product process, including formulation, aseptic filling, freeze drying and capping; support troubleshooting, process improvement and technology transfer.
- Act as Subject Matter Expert (SME) for assigned process steps and laboratory equipment, providing technical expertise and sound judgment during study execution.
- Evaluate, interpret and document experimental results in compliance with GMP, laboratory quality standards and internal procedures, ensuring data integrity and traceability.
- Lead or support laboratory investigations and change controls, identifying root causes and implementing sustainable corrective actions.
- Ensure operational readiness of assigned equipment and systems, including qualification, calibration, cleaning and maintenance of cleanrooms and BSL-1/BSL-2 areas.
- Maintain compliant laboratory operations, including material management and documentation within digital systems (DMS, ELN).
- Prepare and maintain SOPs and controlled documentation in accordance with regulatory and internal requirements.
- Ensure adherence to EHS standards and actively contribute to a safe and compliant working environment.
- Collaborate cross-functionally and communicate technical results clearly in English within an international environment.
In this position you will report to the Manager MSAT Lab DP
What you bring to Takeda:
- Completed vocational training in a scientific discipline (e.g., Laboratory Technician, MTA, BTA, CTA) with further qualification (e.g., Chemietechniker) or several years of relevant professional experience in sterile manufacturing environments such as Vaccines, Biologics, Compounding, Aseptic Filling and/or Lyophilization.
- Proven hands-on experience in GMP-regulated pharmaceutical manufacturing, pilot-scale or laboratory environments.
- Solid theoretical understanding of aseptic techniques and basic microbiology.
- Practical experience operating sterile production and laboratory equipment (e.g., autoclaves, freeze dryers, filling systems, bioreactors, balances, pH meters).
- Confident handling of SOPs, batch documentation and experimental protocols in compliance with GMP requirements.
- Experience with electronic documentation systems (e.g., DMS, ELN) and standard data analysis tools (e.g., MS Excel).
- Experience supporting validation, troubleshooting or technology transfer activities is advantageous.
- High level of accuracy and reliability in experimental execution and documentation.
- Strong quality and compliance mindset with a structured and independent working approach.
- Responsible and safety-conscious behavior in laboratory and cleanroom environments.
- Ability to work effectively in cross-functional teams within an international organization.
- Willingness to continuously develop technical knowledge and contribute to process improvement initiatives.
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 1,200 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.
Locations
Singen, GermanyWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeAbout the company
Takeda
Large Enterprise
Takeda is a global biopharmaceutical company headquartered in Tokyo, Japan, with a rich history spanning over 240 years. Specializing in the research, development, and commercialization of innovative medicines, Takeda focuses on therapeutic areas such as oncology, gastroenterology, neuroscience, and rare diseases. Committed to improving patient outcomes, the company harnesses advanced technologies and scientific expertise to deliver breakthrough therapies and enhance healthcare worldwide. Takeda's dedication to sustainability and social responsibility underscores its mission to strive towards better health for people and communities across the globe.