- Planning, execution, documentation and reporting of biological device related studies (biological compatibility, in use, feasibility and comparability studies) to support clinical studies (I to III), life cycle management activities as well as internal medical device development activities
- Support of special investigations with the main focus on subvisible particle measurements
- Implement method qualifications for several products to support device qualification studies with main focus on subvisible particle measurements using Light obscuration (LO) and Micro Flow Imaging (MFI); including also method development
- Improvements of above stated methods to be state of the art, additionally also for Nano tracking analysis (NTA) and automated visual inspection (Freelate Junior)
- Serving as a subject matter expert on matrix cross-functional project teams
- Authoring and reviewing study plans, study reports, internal preparation forms as well as preparing and supporting of submission documents during IND and BLA
Your Skills and Qualifications:
- At least a Master's level degree with a (bio-) technical focus
- More than 3 years of experience gained within the biopharmaceutical industry or academia in validation and development work on analytical methods and project management.
- Demonstrate an understanding of the technical challenges on different devices depending on product type and/or administration route (hemophilia, gene therapy, immunoglobulins, oncology, …)
- Experience in setting up, implementing and optimization of analytical methods
- Leading studies, including defining the scope, assigning roles, setting objectives and designing strategies
- Dynamic and passionate about science
- Experience of working in multi-disciplinary, multi-cultural teams, demonstrates being an engaged and accommodating team player
- Purpose driven, self-responsible, while maintaining effective time management and accountability for assigned tasks
- Skilled in data interpretation and problem solving and knowledge of statistics
- Good German and strong English language skills
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 3.270,89 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.