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Job Description

About the Role:

The Takeda site in Orth an der Donau looks back on a history of more than 40 years. We are experts in the development, production and analytical testing of biological, plasma and recombinant products.

At Takeda’s Orth an der Donau site, we are at the forefront of digital transformation, implementing state-of-the-art automated and connected analytical systems for biopharmaceutical quality control. As part of the Quality Control Team, you will actively contribute to the qualification, implementation, and continuous optimization of digital and automated laboratory processes supporting the release and stability testing of biological, plasma and recombinant products.

You will collaborate closely with colleagues in Quality Control, Data Science, IT, and Manufacturing at both local and global levels, supporting digital QC and Analytical Instrument Qualification initiatives across several product platforms.

How you will contribute:

• Act as subject matter lead and strategic coordinator for end-to-end Analytical Instrument Lifecycle Management, including full responsibility for CAPEX processes, comprehensive project leadership of complex work packages, oversight and review of User Requirement Specifications, assurance of qualification standards, validation maintenance, audit trail review, and planning as well as execution of decommissioning processes.
• Spearhead the development, evaluation, and optimization of innovative digital solutions and data science applications to sustainably increase laboratory efficiency—e.g., through leadership of advanced projects for database queries or AI-based optimization approaches.
• Hold overall accountability for the conceptualization, implementation, and management of laboratory digitalization projects, coordinating cross-functional stakeholders (e.g., IT, operations, quality management), driving instrument connectivity, data automation, and LIMS integration across systems.
• Champion and serve as a multiplier for the successful implementation and ongoing development of the AGILE Operating System (LabExcellence, AOS tools, etc.), initiate and lead strategic improvement measures across the laboratory, and drive team knowledge sharing and coaching to foster a culture of excellence.

Analytical Instrument Lifecycle Management

• Lead budget planning and CAPEX requests incl. cross-functional alignment (user, engineering/external parties, DD&T, etc.)
• Prepare User Requirement Specifications (URS)
• Ensure data integrity (ALCOA+) and traceability including 21 CFR Part 11 and GxP considerations
• Perform and document analytical instrument qualification & computerized system validation
• Plan and execute instrument decommissioning
• Act as SME within regulatory interactions and audits

AGILE Operating System (LabExcellence, AOS Tools)

• Drive the implementation of LabExcellence tools and Lab of the future initiatives
• Act as mentor and multiplier for employees
• Periodic reporting of progress into global functions
• Continuously optimize laboratory processes

Interfacing Analytical Instruments & LIMS Support

• Lead and execute lab instrument interface projects (e.g. bi-directional instrument – LIMS connectivity) 
• As appropriate, evaluate, select, and manage vendors/partners for instrumentation integrations
• Set up and test interfaces as well as provide support for validation
• Provide support for system issues and LIMS applications
• Interface with local & global DD&T

Data Science

• Perform data analyses and create queries/dashboards/control charts, etc. following SDLC standards
• Mentor and upskill scientists and data practitioners
• Present results and derive recommendations
• Interface with other sites and/or global functions to promote local solutions globally

What you bring to Takeda:

• HTL (Higher Technical College) with a focus on Bioinformatics, Information Technology or Biomedical Analytics, or
• Bachelor’s degree in Bioinformatics, Information Technology, Data and digital sciences, computational biology, bioengineering, or related field (Master´s degree is an advantage)
• 5+ years of relevant professional experience, ideally with leadership or strategic project experience (incl. international projects is a plus)
• Proven track record in managing complex projects and driving innovation in laboratory or analytical settings
• Physical ability to handle laboratory equipment

Preferred:

•            Additional qualifications (e.g., Quality Management, GMP courses, LIMS training, Data Science certificates)

•            Programming and data processing platforms (e.g. Databricks)

•            Several years of professional experience in laboratory environments, analytics, or IT-supported quality management

•            Knowledge of computer sciences and IT-infrastructure

•            Data analysis skills

•            Experience with laboratory software (e.g., LIMS)

•            Familiarity with GxP (Good Practice) environments

Key Skills, Abilities, and Competencies

•            Deep and broad technical expertise in analytical instrumentation, qualification/validation, and lifecycle management

•            Demonstrated ability to develop and implement digital solutions and data science initiatives

•            Strategic, solution-oriented, and visionary mindset

•            Strong influencing, communication and stakeholder management skills

•            High commitment to quality, compliance, and continuous improvement

•            Excellent communication and knowledge-sharing capabilities (including training/mentoring others)

•            Analytical thinking

•            Project management skills

What we offer you:

A competitive remuneration package with a minimum salary of € 4.270,14 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.

• Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
• Commuting allowance or parking space (tax applicable) 
• Comprehensive training programs
• In-house job rotation program
• In-house Canteen with discounts or meal vouchers
• Works council (events, festivals, shopping vouchers, etc.)
• Employee Referral Program
• Employee Recognition Program
• Takeda Resource Groups
• Medical checkups
• Free vaccination program
• Employee discounts 
• Employee Stock Purchase Plan
• Group accident insurance 

More About Us:

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Make History, Change Futures.

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe—colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.

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. 

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