Scientist - Biopharma R&D - Pathogen Safety

Scientist - Biopharma R&D - Pathogen Safety

Eurofins

Bern, Switzerland

Job Description

• Providing guidance on and co-development of pathogen reduction steps for new products in development and for Life Cycle of existing commercial products;
• Evaluating experimental results and contribute to establishment of CMC, Quality by Design, e.g. definition of targets, robustness ranges and critical parameters;
• Collaborating with various functions, including Process Development and Regulatory Affairs on Pathogen Safety relevant matters;
• Providing assessments, regulatory submission documents, position papers, presentations, training materials and data analyses in support of the business needs
• Subject matter expert of pathogen safety aspects of the biological products in scope;
• Providing expertise and documentation with regards to drug product development, manufacturing procedures (pathogen reduction steps, cleaning etc.), starting material selection, and testing;
• Creating efficiencies across the Pathogen Safety organization, i.e. setting up standard procedures (SOPs), white papers, etc.

Qualifications

• University Degree in life sciences: Master or PhD in Virology, Biochemistry, Biology or in a related field;
• 2-5 years of experience in R&D, Quality or a related field in the pharmaceutical industry;
• Strong scientific and analytical skills in biochemistry, virology and/or microbiology. Ability to address autonomously scientific questions;
• Expertise of pathogen safety aspects of the biological products in scope;
• Ability and flexibility to work across international teams (including willingness to participate regularly in global teleconference meetings outside local business hours);
• Excellent command of English language (both oral and written). German skills would be a plus.

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