This Manufacturing Scientist is responsible of supporting other Process Science teams in the areas of Risk Management, Regulatory Submission activities and Data Integrity topics. This is done in close cooperation with the Digital and Data Scientist Group.
The incumbent is in close contact with the site’s manufacturing/quality organizations and global stakeholders to ensure an appropriate level of expertise provided to the site’s operations to guarantee validated, robust and stabile manufacturing processes, global information exchange and harmonized systems throughout Takeda.
Responsibilities in Detail:
- Organize and manage the monthly PFMEA Circle Vienna (platform for the exchange of global and local PFMEA owners and information transfer from the global RM-Community of Practice CoP))
- Keep an overview of ongoing PFMEA revisions
- Responsible for the Risk Management system implementation
- Interaction of stage 2.2 and stage 3 (Continued Process Verification)
- Representation of site specific matters to the global organization, participate in the global Risk Management Community of Practice
- Support the systematic submission activities in MSV (serve as deputy for the lead)
- Cooperation with Regulatory Affairs on priorities, next submissions and activities
- Clarification with Regulatory Affairs which parameters should be part of submission (control section)
- Support all Process Science teams in their submission activities
- Support the Data Integrity sub-project in Manufacturing Sciences
- This is a temporary contract until 30.06.2022; working contract extension is possible
Your Skills and Qualifications:
- University degree in biotechnology, pharmaceutical sciences, process engineering, chemistry or equivalent
- Expertise in Process Failure Mode Effects Analysis (PFMEA)
- Appropriate professional experience with focus on protein biochemistry, bioprocessing and/or PPQ and QbD requirements
- Knowledge related to GMP-requirement, Six Sigma, DMAIC, Data Analysis would be an asset
- Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
- Ability to handle presentations for Inspections, Risk Analyses, Validation Approach guidance without Supervision (after appropriate handover)
- Innovative and creative thinking coupled with ability to structure information
- Experience in project management
- Expertise in the development, process performance qualification, manufacturing and control of biotechnological or pharmaceutical manufacturing processes
- Fluent in German and English
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. We are looking forward to your application!
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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.