Scientist II Functional Biocharacterization and Impurities (All genders)

Job Title: Scientist II Functional Biocharacterization and Impurities

Location: Toulouse
Department: Process & Product Design
Reports To: Manager Functional Biocharacterization & Impurities (FBI)

We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine! Click to learn more.

What You’ll Do:

• Perform routine testing of analytical samples (impurity and potency assays) to support process development

• Participate in Assay Method development & Method qualification for monoclonal antibody, DOE robustness, analyze and present data

• Participate in characterization of early and late stage biotherapeutics (mAbs) using diverse biological assay formats

• Participate in technology development to improve throughput & efficiency, and implement new technologies

• Biosimilarity and comparability assessments

• Technology transfer to Quality Control Laboratory

• Technical document authoring (SOPs, reports, protocols) & author documents to support regulatory fillings

Who you Are:

• PhD with 0-3 years relevant industry experience, MSc with 3-6+ years’ relevant industry experience, with degrees in Biochemistry, Molecular and Cell Biology, Bioengineering, Biotechnology or Life Sciences related field

• Experience developing and applying biological characterization & release methods in a CMC or GMP-like industry setting – potency methods (immunoassays, cell-based assays, SPR & other protein binding kinetic assays i.e BLI)

• Expertise in qualification and/or validation of potency and impurity methods (cell-based assays, immunoassays and qPCR)

• Technical understanding of link between MoA of mAbs and analytical method development, and effects of impurities on biological manufacturing processes

• Experience in statistical analysis

• Hands on experience with plate-based assays and serial dilutions

• Previous experience in biosimilar development is highly desirable

• Use of liquid-handling automation applications will be added value

• Oral and written French & English communication skills

• Desire to work in a fast, collaborative, and team-oriented environment

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.