Senior Expert Science & Technology - Radiochemistry
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Senior Expert Science & Technology - Radiochemistry
The Senior Expert Radiochemistry oversees and executes isotope development projects in close alignment with the Radiochemistry Team Leader and the IDU strategy, serving as a Subject Matter Expert in radiochemistry. The role is prevalently hands-on in development, execution, and/or optimization of radiochemical separation/purification technologies, target-related preparation processes, and (radio)analytical methods. In close collaboration with theragnostic and drug product teams, the SME evaluates radionuclide precursor characteristics / specifications and their impact on product development. Role is complemented by data acquisition, analysis, and interpretation, accompanied by literature research when required. Responsibilities include authoring/revising technical documentation (protocols, reports, SOPs) and supporting change controls, deviations, investigations, and risk assessments as needed. The Senior Expert provides scientific guidance and oversight of internal activities and external partners (CRO/CMO), ensuring high data quality / integrity and timely delivery.
The role ensures compliance with applicable quality, safety, and cGMP requirements (where relevant), maintaining equipment readiness and driving continuous improvement. The role includes supervision and coaching of assigned laboratory associates, ensuring effective resource utilization and active knowledge sharing.
The Senior Expert Radiochemistry reports to the Radiochemistry Team Leader.
About the Role
Major accountabilities:
- In alignment with the Team Leader and IDU strategy, contribute to the design and planning of scientific experiments and analysis / interpretation of experimental data; prepare high-quality summaries, reports and other documentation to support internal decision-making and regulatory/registration needs.
- Contribute to the development, optimization, and implementation of efficient, robust and safe radionuclide-related processes and (radio)analytical methodologies, in compliance with relevant quality and regulatory standards (including cGMP where relevant), within agreed timelines and budgets; communicate key advancements and challenges.
- Plan and execute hands-on laboratory work safely and efficiently; operate, maintain and troubleshoot a broad range of laboratory and analytical equipment, ensuring proper calibration, qualification, documentation and adherence to internal standards.
- Ensure adherence to organizational workflows, procedures, documentation practices and data integrity expectations across laboratory activities.
- Provide scientific and technical guidance, actively fostering knowledge exchange within the team and across interfaces; provide technical oversight of external partners (CRO/CMO), including review of protocols, data packages, and deliverables.
- Author, review, and maintain technical and scientific documentation (protocols, reports, SOPs) and support quality-system activities (change controls, deviations, investigations, CAPA input, and risk assessments) where needed.
- Present scientific/technical results internally and contribute to publications, presentations and patents as appropriate, ensuring timely and accurate reporting aligned with internal governance and regulatory requirements.
- Supervise, mentor and coach assigned lab and scientific associates (and, where applicable, coordinate external contributors), ensuring efficient resource utilization, clear priority setting and appropriate levels of guidance based on experience and expertise.
Minimum Requirements:
- Master Degree in Chemistry or related scientific discipline (PhD is a plus), with strong background in radiochemistry and / or (radio)analytical chemistry
- 4-6 years of relevant experience in radiochemistry / radiopharmaceutical or isotope development, including hands-on work with radioactive materials, radionuclide identification / characterization; strong knowledge of ALARA principles
- Practical experience working in shielded fume hoods, hotcells and/or gloveboxes; experience using tele-manipulators is strongly desired
- Demonstrated experience with HPGe spectrometry and related data acquisition and analysis software. Knowledge or strong willingness to rapidly master key analytical tools such as alpha spectroscopy, ICP-MS, ICP-OES, iTLC and HPLC.
- Strong working knowledge of several of the following: isotope production technologies (e.g., cyclotron, neutron irradiation, generators, etc.), liquid phase chemistry and chromatographic separations, complexation / chelation chemistry, colloid formation, trace-metal control, radiolytic degradation, radiometric techniques beyond spectroscopy (e.g., dose calibrators, liquid scintillation counting, imaging techniques), electrochemistry, molecular plating, precipitation / chemical bath depositions, decontamination chemistry, metrology, dosimetry. Strong knowledge of chemometrics and statistical data analysis is highly desired.
- Experience working in a regulated environment with strong documentation practices and data integrity; exposure to cGMP and analytical method development and validation / verification (as applicable)
- Proven experience in supervising staff and leading projects, ideally within international and multidisciplinary development teams.
- Strong project management, interpersonal and communication skills (written and oral), with a collaborative, team-oriented mindset.
- Result- and quality-oriented, with the ability to manage conflicting interests, balance priorities and make pragmatic compromises to ensure project progress.
Languages :
- Italian and English
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
