Job Description
Plan, execute, and report impurity profiles and impurity-based comparability studies for manufacturing process changes and process transfers.
Perform impurity profile data control, statistical impurity profile data evaluation and correlation analyses to support deviations and process changes and update tracking tools.
Prepare presentations to support investigations related to process changes, process improvements, deviations/quality issues, and general impurity knowledge.
Prepare impurity profile data to support data management.
Support storage and control of impurity profile retain samples.
Support global regulatory affairs in impurity profile field by updating impurity chapters in registration dossiers and responding to inquiries from authorities.
Order plasma product samples and plan sample analyses with other departments.
Participate in local and global projects.
Qualifications
Master or PhD degree in Biochemistry, Biotechnology or Biology.
2-3 years experience in the Pharmaceutical Industry.
Strong scientific background in protein biochemistry, plasma protein products, manufacturing processes, protein analytics, particles characterization, and quality assurance.
Technical expertise in the purification processes for plasma purification and proteins.
Strong background in Statistics.
Experience in data analysis and report writing.
Proficiency in electronic data evaluation, general computing, and software applications.
Strong communication skills.
Desirable experience working in a GMP regulated environment, preferably in the pharmaceutical industry.
Experience in project-oriented, multidisciplinary, and multicultural environments.
Fluent in German and English, both oral and written (minimum C1 level).
Additional Information
Hybrid Work Model
2-3 days of home office possibility.
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.
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.
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