This Manufacturing Scientist is essential to ensure continuous patient supply for the products supported by the Technical Services Vienna team. The role supports business critical programs to enable yield increase, increase of manufacturing capacity and increase of process robustness of the respective-processes. We are looking for an excellent communicator with a passion for optimization.
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 submission teams and responses to authority requests with process expertise and data analyses
- Quality by Design for legacy products, development of control strategy, PFMEA updates (after sufficient on-the-job training)
- Representation at internal and external authority audits
- Best-practice sharing with local and global teams
- Lab work is NOT expected
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
- Experience in technical problem solving and statistics
- 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
Innovative and creative thinking are a must
A sense of humor and an ability to handle stressful situations will bring you a long way
- Solid working knowledge of current GMP and ICH guidelines would be an advantage
- Green Belt certification would also be ideal
We are open to applications from candidates with no industry experience or limited work experience (Berufseinsteiger)
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.
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 € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application!