Eurofins Scientific is an international life sciences company that offers customers from various industries a unique range of analytical services to make life and our environment safer, healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on, Eurofins works with the world's largest companies to ensure the products delivered are safe, their ingredients are authentic and labeling is accurate. The company is a leading global provider of analytics for food, environmental, pharmaceutical and cosmetic products as well as contract research (CRO) services.
Eurofins Professional Scientific Service (PSS) is a global insourcing solution for our customers. Together with the customer, we define a project for the required services that our Eurofins employees should provide at the customer's location. During the ongoing project, the responsibility for project management, the previously defined laboratory services and the deployment of our employees in this project lies with Eurofins PSS.
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 of 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.
* 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.
Opportunities for Growth: As part of our commitment to employee development, we offer abundant growth opportunities at Eurofins PSS.
Equal Opportunity Employer Statement: At Eurofins PSS, we are dedicated to being an equal opportunity employer, embracing diversity, and cultivating an inclusive workplace.
#J-18808-Ljbffr