Isotope Project Lead (Associate Director S&T)

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Ivrea; In loco; EUR 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Novartis Ivrea site is seeking an Isotope Project Lead (IPL) to drive expertise in radioisotope production and purification, optimize new technologies, and support LCM across product life cycles. You will coordinate cross-functional teams and ensure timely progress within budget in collaboration with global centers and CMOs.

The role requires strong leadership, GMP awareness, regulatory understanding, and exceptional communication.

Competenze

• Bachelor's degree in Chemical Engineering, Pharmaceutical Technology, or equivalent.
• Desirable MSc., PhD or equivalent experience.
• Desirable degree in Radiochemistry and strong scientific knowledge in nuclear medicine
• Minimum of 5 years directly related scientific experience
• Proven Project Leadership across all project phases
• Pharma, GMP, Validation and Regulatory understanding
• Strong data handling and applied statistics experience
• Excellent verbal and written communication skills
• Italian language is required as site language

Mansioni

• Manage inter functional project plan and budget using the Project Planning tool or System
• Identify issues and potential bottlenecks within projects and proposes options
• Contribute to the Radioisotope TRD-related activities
• Ensure constant technological survey on the field of radioisotopes production
• Apply scientific/technical expertise to identify new programs of interest for the company
• Participate in development programs around isotopes with global strategy
• Identify external partners for collaboration to develop new production technologies
• Adhere to budgets, schedules, and performance requirements
• Represent the area in Global Project Teams for strategy and approvals
• Report technical complaints/adverse events related to Novartis products within 24 hours

Conoscenze

Project leadership

Data handling

Statistics

Risk assessment

Regulatory knowledge

Communication

Problem solving

Italian language

Formazione

BSc in Chemical Engineering/Pharmaceutical Technology

MSc/PhD desirable

Radiochemistry degree desirable

Strumenti

Project Planning tool

Statistical tools

Descrizione del lavoro

Job Description Summary

Location: Ivrea, Italy #onsite

Role Purpose: Act as Isotope Project Lead (IPL) by providing the specialist knowledge and expertise as Subject Matter Expert (SME) of radioisotope production and purification with particular focus on assessing, developing, and optimizing new technologies that support RLT products Life Cycle Management (LCM). Develop, optimize and transfer radioisotopes production and purification/separation processes. This is done in close collaboration with the relevant development centers, and Contract Manufacturing Organizations (CMOs).

Major accountabilities

• Manage inter functional project plan and budget using the Project Planning tool or System
• Identify issues and potential bottlenecks within projects and proposes options
• Contribute to the Radioisotope TRD-related activities.
• Ensure constant technological survey on the field of radioisotopes production.
• Apply scientific/technical expertise to identify new programs of interest for the company and support their development from early evaluation up late phase supply.
• Participate to development programs and activities around isotopes in adherence with global Isotope strategy and objectives within agreed timelines and budget, timely report key advancements and challenges.
• Identify strategic external partners for the activation of research collaboration agreement to develop new production technologies/ access to innovative isotopes.
• Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
• Representatives area as core member in the Global Project Teams for defining global scientific strategy for development up to submission and approval in major markets of assigned product(s).
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Minimum Requirements

• BSc. in Chemical Engineering, Pharmaceutical Technology, or equivalent scientific degree.
• Desirable MSc., PhD or equivalent experience.
• Desirable degree in Radiochemistry and strong scientific knowledge in nuclear medicine
• Successfully demonstrated several years (minimum of 5 years) of directly related experience in a scientific area or Ph.D. or equivalent
• Proven Project Leadership in all project phases
• Proven process understanding (Pharma, GMP, Validation and Regulatory aspects).
• Sound experience of data handling and applied statistics is a must.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Quality-oriented with attention to detail
• Excellent verbal and written communication skills
• Excellent problem solving and decision-making skills
• Defining and implementing productivity improvement measures.
• Italian language needed as a site language

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.

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.