This expert function is responsible for controlling of the process stability, evaluation of any impact on product quality, technical problem solving, and yield improvement. The manufacturing scientist supports our manufacturing and quality partners with process and product know-how and statistical expertise and sets preventive measures to assure stable processes and sustainable product supply.
About the position:
- Monitoring, controlling, and improvement of the manufacturing processes of assigned products
- Identification of process monitoring and yield trends and development of consequent measures to ensure stable manufacturing processes and yield improvement
- Lead or assist in deviation, complaint and failure investigations, product impact investigation, and root-cause analysis
- Evaluation of changes (manufacturing processes, analytical testing, and materials)
- Product related review and approval of manufacturing and validation documents
- Support of authority submissions and responses to authority requests with authoring, process expertise and data analyses
- Quality by Design for legacy products, update of PFMEAs, development of control strategy
- Representation at internal and external authority audits
- Best-practice sharing with local and global teams
Skills you need:
- University degree in Biochemistry, Biotechnology, Biostatistics, Biology, Chemistry, Pharmaceutical Technology, or similar qualification
- Excellent communication skills (written and verbal) in German and English, including experience in presenting complex topics in front of multidisciplinary audiences
- Green Belt certification or equivalent preferred
- Experience in technical problem solving and statistical process control
- Solid working knowledge of current GMP and ICH guidelines
- Innovative and creative thinking
- Team player with excellent interpersonal skills and capability to influence and drive change agendas without formal authority
- Ability to take the initiative and work independently while developing and maintaining strong communication with the stakeholders
- Basic knowledge of manufacturing and/or biochemistry of coagulation factors
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.