Job Description
1. Build up of reference data base according to impurity standards in collaboration with Data Management Team
2. Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers
3. Support in information gathering of product and process knowledge (generation of flowcharts, deviation history, etc.)
4. Support in defining and organizing future sample management procedure
5. Support definition and alignment of impurity profile analytical testing program
6. Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and general impurity knowledge
7. Support global regulatory affairs in impurity profile field by updating impurity chapters in registration dossiers and responding to inquiries from authorities
8. Participate in local and global projects
Qualifications
9. Advanced degree (Master or equivalent) in Biochemistry, Biotechnology or Biology
10. 1-2 years experience in the Pharmaceutical Industry
11. Scientific background in protein biochemistry, plasma protein products, manufacturing processes, protein analytics, particles characterization, and quality assurance
12. Expertise in Data Base creation and data management (bioinformatics)
13. Strong background in Statistics
14. Experience in project-oriented, multidisciplinary, and multicultural environments
15. Strong communication skills
16. Fluent in English (oral and written) and German (oral), both minimum C1 level
Additional Information
2-3 day home office possible
Company Culture:
At Eurofins PSS, our company culture is deeply rooted in our four core values: Teamwork, Integrity, Superlative Customer Satisfaction, and Productivity. We believe in fostering a collaborative environment where every team member is encouraged to contribute their unique expertise and ideas. Our commitment to integrity drives us to uphold the highest ethical standards in all our endeavors. We strive for superlative customer satisfaction by understanding and exceeding our clients' expectations. Embracing productivity, we continuously seek innovative ways to streamline processes and deliver exceptional results. Together, these values form the foundation of a supportive and empowering workplace, enabling us to achieve excellence in everything we do.
Opportunities for Growth:
As part of our commitment to employee development, we offer abundant growth opportunities at Eurofins PSS. You'll have access to learning and development programs, coaching & mentorship, and the chance to take on challenging projects, empowering you to achieve your professional aspirations.
Equal Opportunity Employer Statement:
At Eurofins PSS, we are dedicated to being an equal opportunity employer, embracing diversity, and cultivating an inclusive workplace where every individual's unique background and perspective are valued, respected, and celebrated.