Biotransformation Specialist for Radioligand Therapeutics
Vor 7 Tagen
Job ID REQ-10028558
SummaryMore than 100,000 people across 140 countries are working for Novartis to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering, and to enhance the quality of life.
The Pharmacokinetic Sciences (PKS) Department within the Novartis BioMedical Research (BR) Division in Basel, Switzerland is recruiting for a scientist with extensive experience working with radioligands to join their global Biotransformation team (with groups in Europe and North America) to strengthen the department’s capabilities for the development and clinical monitoring of radioligand therapies (RLTs).
As a biotransformation expert, you will develop state-of-the-art analytical methodologies for metabolite profiling of RLTs using HPLC coupled to ICP-MS, radiodectors and/or high-resolution mass spectrometry. You will plan and execute tailored experiments, maintain the laboratory environment/instruments, and support the development of new technologies. An essential part of this role involves monitoring of radio-metabolite assessment of RLTs in clinical trials under GCP. These analyses will be performed at external clinical sites and CROs using gamma counters and HPLC radiodectors. You will collaborate with clinical teams and external partners to ensure excellent study design and timely reporting of high-quality radio-metabolite assessment studies.
As the successful candidate you will be adaptable, independently motivated, and challenge driven with a history that demonstrates strong interpersonal skills that encourage successful collaborative working relationships. In this role, you will represent the ADME line function in PKS sub-teams and project teams, present findings in teams, document results in internal and external reports/publications and contribute to registration documents.
Therefore, the ideal candidate should have a good understanding of the drug discovery/development process for RLTs, have the ability to design, oversee, and interpret various types of biotransformation studies and have a keen interest in implementing/optimizing experimental methods internally and externally. The successful candidate will deliver high quality timely results on internal and/or outsourced studies and represent those at cross-functional teams and department meetings.
Your main accountabilities will include:
- Design and execution of biotransformation studies to assess RLT metabolic pathways and structural elucidation of metabolites
- Organize and prepare experimental protocols and study reports with upload of results to a centralized database
- Presentation of key findings to project teams and/or other stakeholders
- Monitoring data collection during clinical trials, ensuring adherence to study protocols and regulatory requirements
- Coordination and monitoring of clinical RLT studies run under GCP
- Assure quality standard guidelines and safe work practices are applied while working in the laboratories
- Degree in organic/analytical/biochemistry with Biotransformation experience in an industry setting
- A very good understanding of handling of radioisotopes is essential for this role
- Experience in monitoring of clinical trials would be desirable
The ideal candidate will draw from any of the following key skillsets:
- Excellent (hands-on) experience with UPLC, mass spectrometry, especially high-resolution mass spectrometry and ICP-MS
- Extensive hands-on experience with radiometabolite assessment and radiodetection techniques
- Good understanding of in vitro and in vivo drug metabolism of peptides and small molecules
- Good attention to detail, an analytical investigative and questioning nature, with an innovative solution-oriented approach
- A sharp and objective intellect, experienced in balancing big picture thinking with an investigative nature, drilling into detail as appropriate
- Well-developed interpersonal skills with good presence, experienced presenter, and excellent communication skills
- A self-starter and decision maker with an open, confident and persuasive manner who succeeds through influence
- Good planning, prioritization, problem solving and organizational skills
- Resilient, energetic and enthusiastic with the ability to respond constructively to challenging new ideas and feedback
- Team player, ability to be flexible and adapt to a changing environment.
- Good IT skills particularly Word, Excel and PowerPoint
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