As part of the local Process Science team Hematology & Biosurgery, you will be responsible for controlling the process stability, by means of planning, coordination, implementation and documentation of process validations, evaluation of any impact on product quality, supporting technical problem solving teams and yield improvements in the product area of responsibility.
In this position, you will be in close contact with the site’s manufacturing and quality organizations, as well as global stakeholders to ensure an appropriate level of expertise is provided to the site’s operations to guarantee validated, robust and stabile manufacturing processes.
Your (new) Opportunity:
- Assurance that all internal and external requirements regarding GMP, EHS, and safety are fulfilled
- Assure robustness and stability of Vienna manufacturing processes for the product you are responsible for
- Main Responsibility: Planning and execution of Process Installation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV)
- Quality by Design for legacy products, update of PFMEAs, development of control strategy
- Support process and yield improvement initiatives
- Evaluate the suitability of new technologies for the implementation in manufacturing and work with Manufacturing Science and the plant operation teams to ensure successful transition to the manufacturing floor
- Product related review and approval of manufacturing documents
- Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis
- Support of authority submissions and responses to authority requests with authoring, process expertise and data analyses
- Support quality and compliance of products within area of responsibility
- Support timely deviation and change control evaluations
- Best-practice sharing with local /global Process Sciences teams
Your Skills and Qualifications:
- University degree in biotechnology, pharmaceutical sciences, process engineering, chemistry or related area of natural sciences
- Experience in the pharmaceutical industry and knowledge of GMP
- Appropriate professional experience with focus on protein biochemistry, bioprocessing and PPQ & QbD requirements
- Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
- Fluency in German AND English
- Ability to work in cross-functional teams and take responsibility for projects
- Knowledge related to Six Sigma, DMAIC, Data Analysis would be a major plus
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 € 3.323,20 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.
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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.