Senior Scientist (Liquid Sterile Formulation)
- Ivrea, Italy
AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
Design, plan, perform, interpret and report the results of technical development of liquid sterile radiopharmaceuticals. Seeks proactively for support and coaching from Project Leader, scientific expert team members during the whole process if necessary.
• Serve as formulation subject matter expert (SME) in project teams to provide strategic and experimental input to team in developing new drug products
• Lead the development of formulations and manufacturing processes of liquid sterile radiopharmaceuticals.
• Lead the development and the qualification of analytical methods in accordance with ICH guidelines and with specific references to quality control of radiopharmaceuticals.
• Lead the transfer of analytical or manufacturing procedures for ready to use radiopharmaceuticals to TechOps
• Draft the CMC documents required for enabling regulatory submissions (IND/IMPD, Module3/NDA).
• Provide scientific and technical guidance. Coach team members as needed
• Work with appropriate internal and external partners (e.g. CRO) to identify, prioritize, and address critical drug product needs
• Give guidance to team members and work according to appropriate SOP's, GLP, GMP, OQM, HSE, ISEC and AAA / Novartis guidelines.
• Actively interaction with other CMC team members for the achievement of project's goals
Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of relevant experience within the pharmaceutical/biotech industry or a Master's degree with a minimum of 5 years experience
Good knowledge of English (oral and written). Desirable knowledge of Italian
• Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms
• Technical expertise and thorough understanding of drug product production and control technologies
• Experience with outsourcing and overseeing work done by CRO/CMOs
• Experience with software used in pharma analysis
• Experience in writing documents for regulatory submissions and responding to health authority questions
• Good presentation skills and scientific/technical writing skills
• Good communication skills, basic coaching skills
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