Job Description
1. Providing guidance on and co-development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products
2. Evaluating experimental results and contribute to establishment of CMC, Quality by Design, e.g. definition of targets, robustness ranges and critical parameters
3. Collaborating with various functions, including Process Development and Regulatory Affairs on Pathogen Safety relevant matters
4. Providing assessments, regulatory submission documents, position papers, presentations, training materials and data analyses in support of the business needs
5. Subject matter expert of pathogen safety aspects of the biological products in scope
6. Providing expertise and documentation with regards to drug product development, manufacturing procedures (pathogen reduction steps, cleaning etc.), starting material selection, and testing
7. Creating efficiencies across the Pathogen Safety organization, i.e. setting up standard procedures (SOPs), white papers, etc.
Qualifications
8. University Degree in life sciences: Master or PhD in Virology, Biochemistry, Biology or in a related field
9. 2-5 years of experience in R&D, Quality or a related field in the pharmaceutical industry
10. Strong scientific and analytical skills in biochemistry, virology and/or microbiology. Ability to address autonomously scientific questions
11. Expertise of pathogen safety aspects of the biological products in scope
12. Ability and flexibility to work across international teams (including willingness to participate regularly in global teleconference meetings outside local business hours)
13. Excellent command of English language (both oral and written). German skills would be a plus
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.