The Manufacturing Scientist function is responsible for controlling the process stability, evaluation of any impact on product quality, technical problem solving, and yield improvement. The role supports the teams 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 job:
- Monitoring, controlling, and improvement of the manufacturing processes of assigned products (continuous process verification)
- Development of consequent measures to ensure stable manufacturing processes and yield improvement
- Leading or assisting 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
- Authoring of submission chapters within responsibility
- Support of submissions and responses to authorities
- Providing expert feedback to authority requests with 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
Skills you need:
- University degree in Biochemistry, Biotechnology, Biostatistics, Biology, Chemistry, Pharmaceutical
- Technology, or similar qualification
- Quality and GMP knowledge
- Fluent German and good knowledge of English
- Knowledge of manufacturing and/or biochemistry of coagulation factors
- The following qualifications would be optimal: Experience in Manufacturing and/or process development and/or process optimization, Green Belt certification or equivalent, laboratory experience
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 € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.