Scientist II Functional Biocharacterization and Impurities
il y a 6 jours
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
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged
The future is ours to shape
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.
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