Bioanalytical Scientist
vor 3 Wochen
The Bioanalytical Scientist will be part of an agile and highly efficient integrated R&D team being responsible for managing and overseeing all bioanalytical activities for TUBULIS innovative ADC candidates. The incumbent will work closely with the research, preclinical and clinical organization as well as with CROs and consultants. Therefore, you must be highly adept at building and managing relationships across various functions, and positioning results with a deep scientific understanding as to how the findings relate to early lead selection through development.Your missionResponsible for development, transfer and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of candidate ADCs and any concomitant/interaction compound in given projects to support non-clinical (GLP) and clinical (GCP) studies Technical monitoring during bioanalytical method development, validation, and sample analysisOutsourcing and managing activities in Bioanalytics (from proposal generation to report approval); resource and time planning, coordination and administrative management of studies with CROs Ensure validity, accuracy, relevance and completeness of scientific content in non-GxP and GLP/GCP research and regulatory documents Ensure full compliance with the current global and local bioanalytical guidelines and GxPs Responsible for original writing, editing and review of documents or regulatory submissionYour profileQualifications:A minimum of 1 year of relevant industry experience in pharmaceutical or biotech companyKnowledge of PK and Immunogenicity science inside a complex research and development setting in a biotech organization of pharmaceutical companyIn depth knowledge in bioanalytical assay development to support non-clinical and clinical studiesIn depth understanding of the drug development process and of non-clinical development. Strong ability to manage multiple studies simultaneously and to be able to assist in troubleshooting when instrument or assay problems ariseExperienced in authoring and providing regulatory guidance to team members on technical reports, suitable for inclusion in registration dossiersFamiliar with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research and clinical researchPreferred Qualifications:Excellent communication skills and proven ability to collaborate with interdisciplinary teams and CROs. Must be highly organized and extremely analytical with strong problem-solving skillsAbility to align activities with company objectivesAble to work independently and work well in a team and in a fast-paced environmentWhy us?At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.Impact that matters: Contribute to breakthrough therapies.Global mindset: Work in an international, diverse team.Grow & thrive: Develop your career in a supportive, fast-moving environment.Innovation every day: Push boundaries with cutting-edge science.At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
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Post Doc
vor 2 Wochen
Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit**The Position**: We are seeking an enthusiastic, highly motivated and creative postdoctoral scientist to join our group “Development Operations Germany”. We are focusing on the development of mammalian cell-culture upstream, downstream, and analytical processes for the production of various biopharmaceutical protein formats. The Post Doc project will...
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Senior Fellow Ets
vor 1 Woche
Munich, Deutschland Hexal AG Vollzeit.Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...