The QC Senior Scientist is a key role for implementation and maintenance of QC test methods for both Plasma and Recombinant product release tests.
The role acts as project lead and author of respective documents (e.g. protocols and reports) and interacts with both, the local Austria Shire QC laboratories as well as QC labs and team colleagues at the other Shire locations globally in EU, US, as well as stakeholders from R&D in case of newly developed assays for transer to QC, and Regulatory for license applications and variations.
- Assures GMP compliant and timely implementation and maintenance of validated status of assays
- Lead and drive analytical assay investigations (OOS, CAPA, etc)
- Identify, lead and drive improvements or remediation for analytical assays
- Lead and Coordinate analytical method validation, author respective documents
- assay investigation/improvement acitivities
- Support Audits, assure inspection readiness
- Support global harmonization and simplification
- Knowledge sharing of problems that were found and share/present solutions to drive continuous improvement
- Experience with analytical methods, preferentially within a GMP QC laboratory, e.g. HPLC, protein determination, GC, ELISA, etc.
- Experience with respective regulatory/GMP requirements
- Experience in problem solving (facilitation and application of tools), risk management and decision making
- Knowledge about analytical method validation and critical reagent qualification
- Basis statistical knowledge and experience with data analysis
- Fluency in German and English
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.