369996BR
May 17, 2023
France
Job Description
As our TRD (Technical Research & Development) Scientist, you will work in the development of new radiopharmaceuticals manufacturing processes for internal and/or external partners following the R&D and GMP requirements related to initial feasibility tests up to commercialization.
Your responsibilities will include, but are not limited to:
• Developing within the laboratory, efficient and robust processes for the drug products manufacturing (selection of the synthetic route, drug formulation, design of the cassette and reagents, programming of the automatic sequence) and quality control (design and validation of analytical methods).
• Ensuring that objectives and deliverables are well understood and deliver high level of laboratory work. Proactively seeking support and coaching from the TRD Manager or related Technical Experts.
• Communicating key issues and any other critical topics in a timely manner to direct line function (TRD Manager) and to any other relevant project team member.
• Ensure the preparation of correct, comprehensible, structured, full and legible documentation following all internal guidelines. Support preparation of documentation and literature search as required.
• Participate in the transfer of analytical and/or manufacturing procedures in an international and multi-site landscape.
• Contribute to optimization of processes or technical activities in assigned projects.
• Contribute to the maintenance of the laboratory resources (instruments calibration and maintenance, analytical methods validations, consumables stock and procurement).
• Maintain a clean, functional, and organized workspace (manufacturing line and QC laboratory), ensure correct and timely filling of logbooks.
• Follow the appropriate SOP’s, good laboratory and manufacturing practices, security standards and Advanced Accelerator Applications MI (Molecular Imaging) / Novartis guidelines.
• Note: Potential involvement in night shift work as per project needs.
Closing date for applications: 31 May 2023
Your responsibilities will include, but are not limited to:
• Developing within the laboratory, efficient and robust processes for the drug products manufacturing (selection of the synthetic route, drug formulation, design of the cassette and reagents, programming of the automatic sequence) and quality control (design and validation of analytical methods).
• Ensuring that objectives and deliverables are well understood and deliver high level of laboratory work. Proactively seeking support and coaching from the TRD Manager or related Technical Experts.
• Communicating key issues and any other critical topics in a timely manner to direct line function (TRD Manager) and to any other relevant project team member.
• Ensure the preparation of correct, comprehensible, structured, full and legible documentation following all internal guidelines. Support preparation of documentation and literature search as required.
• Participate in the transfer of analytical and/or manufacturing procedures in an international and multi-site landscape.
• Contribute to optimization of processes or technical activities in assigned projects.
• Contribute to the maintenance of the laboratory resources (instruments calibration and maintenance, analytical methods validations, consumables stock and procurement).
• Maintain a clean, functional, and organized workspace (manufacturing line and QC laboratory), ensure correct and timely filling of logbooks.
• Follow the appropriate SOP’s, good laboratory and manufacturing practices, security standards and Advanced Accelerator Applications MI (Molecular Imaging) / Novartis guidelines.
• Note: Potential involvement in night shift work as per project needs.
Closing date for applications: 31 May 2023
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
What you’ll bring to the role:
Education
• Minimum: Masters degree level in a Scientific field
• Desirable: Doctorate in a scientific discipline, preferentially medicinal, organic, complexation and/or analytical chemistry or equivalent
• Desirable: Specialization in radiochemistry
Experience
• Minimum: 3 years experience working as principal scientist or equivalent in the field of radiochemical and/or radiopharmaceutical development.
• Adequate scientific and technical knowledge in synthetic, analytical and pharmaceutical disciplines.
• Good knowledge of laboratory and/or technical tools. Experience in software(s) used in QC or pharmaceutical analysis.
• Awareness of safe handling of chemicals, potentially hazardous materials and equipment.
• Knowledge of GMP production and quality control of pharmaceuticals.
• Desirable: experience in radiopharmaceuticals’ GMP production.
• Desirable: Recognized experience in the development of covalent and/or complexation chemistry in the radiopharmaceutical fields together with automated synthesis and GMP manufacturing processes.
Languages
• Fluent English (both written and spoken) is required.
• Desirable: Proficient French (both written and spoken) as this is the site language.
Personal Profile
• Autonomous, accountable and organized. Problem-solving skills.
Education
• Minimum: Masters degree level in a Scientific field
• Desirable: Doctorate in a scientific discipline, preferentially medicinal, organic, complexation and/or analytical chemistry or equivalent
• Desirable: Specialization in radiochemistry
Experience
• Minimum: 3 years experience working as principal scientist or equivalent in the field of radiochemical and/or radiopharmaceutical development.
• Adequate scientific and technical knowledge in synthetic, analytical and pharmaceutical disciplines.
• Good knowledge of laboratory and/or technical tools. Experience in software(s) used in QC or pharmaceutical analysis.
• Awareness of safe handling of chemicals, potentially hazardous materials and equipment.
• Knowledge of GMP production and quality control of pharmaceuticals.
• Desirable: experience in radiopharmaceuticals’ GMP production.
• Desirable: Recognized experience in the development of covalent and/or complexation chemistry in the radiopharmaceutical fields together with automated synthesis and GMP manufacturing processes.
Languages
• Fluent English (both written and spoken) is required.
• Desirable: Proficient French (both written and spoken) as this is the site language.
Personal Profile
• Autonomous, accountable and organized. Problem-solving skills.
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
France
Marseille
AAA SA
Research & Development
Full Time
Regular
No
