Build up of reference database according to impurity standards in collaboration with Data Management Team.
Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers.
Support in gathering information on product and process knowledge (e.g., generation of flowcharts, deviation history).
Assist in defining and organizing future sample management procedures.
Support the definition and alignment of impurity profile analytical testing programs.
Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and impurity knowledge.
Collaborate with global regulatory affairs by updating impurity chapters in registration dossiers and responding to authority inquiries.
Participate in local and global projects.
Qualifications
* Advanced degree (Master or equivalent) in Biochemistry, Biotechnology, or Biology.
* 1-2 years of experience in the Pharmaceutical Industry.
* Background in protein biochemistry, plasma protein products, manufacturing processes, protein analytics, particle characterization, and quality assurance.
* Experience in database creation and data management (bioinformatics).
* Strong background in statistics.
* Experience working in multidisciplinary, multicultural, project-oriented environments.
* Fluent in English (oral and written) and German (oral), both at minimum C1 level.
Additional Information
2-3 days of home office possible.
Company Culture
Eurofins PSS values teamwork, integrity, customer satisfaction, and productivity. We foster a collaborative, ethical, and innovative work environment where every team member's contributions are valued.
Opportunities for Growth
We offer learning and development programs, coaching, mentorship, and challenging projects to support your professional growth.
Equal Opportunity Employer
We are committed to diversity and inclusion, valuing every individual's background and perspectives.
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