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 mission
* Responsible 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 analysis
* Outsourcing 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 submission
Your profile
Qualifications:
* A minimum of 1 year of relevant industry experience in pharmaceutical or biotech company
* Knowledge of PK and Immunogenicity science inside a complex research and development setting in a biotech organization of pharmaceutical company
* In depth knowledge in bioanalytical assay development to support non-clinical and clinical studies
* In 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 arise
* Experienced in authoring and providing regulatory guidance to team members on technical reports, suitable for inclusion in registration dossiers
* Familiar with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research and clinical research
Preferred 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 skills
* Ability to align activities with company objectives
* Able to work independently and work well in a team and in a fast-paced environment
Why 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.