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 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
Company Insights https://youtu.be/ly_8oO-iJeU
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 2,438.75 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.