Your (new) Opportunity:
- Planning and execution of biological device related studies (biological compatibility, in use, feasibility and comparability studies)
- Creating study plans and reports, editing and reviewing technical documents (i.e., ASQ documents)
- Scientific review of method qualification studies as well as biological compatibility, in use, feasibility and comparability studies
- Serving as team representative and subject matter expert in project teams
- Authoring and reviewing of CMC sections of regulatory documents; involvement in the regulatory documents such as IMPD, IND, NDA and MAA
- Instructing laboratory staff as required
Your Skills and Qualifications:
- MSc or PhD in biochemistry or related discipline
- 3+ experience gained within the biopharmaceutical industry or academia on development work with proteins with a focus on biophysical methods related to particle analysis (e.g., MFI, LO), additional experience in formulation development beneficial
- Experience in setting-up, implementing and optimization of analytical methods
- First experience supervising teams is considered an asset
- Solid knowledge of statistics and project management
- Professional English and solid German 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. For more insights into Takeda click here.
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 € 3 389,68 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.
AUT - Wien - Industriestrasse 72