Industrie Pharmaceutique jobs in Deutschland

Senior Scientist Functional Biocharacterization and Impurities (all genders) page is loaded

Permanent position

General Summary:

Just Evotec Biologics EU is seeking a motivated and creative Senior Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics.

The new scientist will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional & potency assessment and impurity monitoring of biotherapeutics (mAbs). As a key member of the analytical group, the successful candidate will have experience in immunoassay, cell-based assay and qPCR method development and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in biosimilar development, participation in CMC (Chemistry, Manufacturing, and Controls) teams and experience authoring regulatory documents is highly desirable.

The ideal candidate has strong written and verbal communication skills in english, multitasks effectively, works well independently and in teams.

Missions and responsibilities :

• Development & Qualification of biological functional analytical methods (immunoassays, kinetic and cell-based assays)
• Analyze and present data internally and at customer’s meetings
• Lead characterization of early and late stage biotherapeutics (mAbs) using diverse biological assay formats
• Lead biosimilarity and comparability assessments
• Lead technology transfer to Just’s Quality Control laboratory
• Technical document authoring & author documents to support regulatory filings
• Contribute to team development by mentoring junior scientists

Knowledge, skills and abilities :

• Experience in biosimilars characterization specialized in mAbs
• Experience developing analytical methods in a CMC or GMP-like industry setting
• Experience developing and applying biological characterization methods (e.g. cell-based assays, Fc receptors binding kinetic assays – SPR & BLI, immunoassays) and in technology development pertinent to impurities
• Expertise in qualification and/or validation of release potency and impurity methods
• Strong technical understanding of link between MoA and analytical method development; and effects of impurities on biological mAbs manufacturing processes
• Strong analytical skills and experience in statistical analysis
• Strong oral and written English communication skills
• French speaking would be an added value

Experience and education :

• PhD with 5+ years relevant industry experience, MSc with 10+ years’ industry experience degrees in Biochemistry, Molecular and Cell Biology, Bioengineering/Biotechnology or related field

Other information :

• 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.

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn .

Please click on the link below to access and review our Privacy Information for Applicants: