Isotope Project Lead (Associate Director S&T)

Novartis Italia; Ivrea; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Novartis Italia in Ivrea, onsite, seeks an Isotope Project Lead (IPL) as SME in radioisotope production and purification to support LCM activities.

You will lead cross-functional programs, optimize production processes, and collaborate with development centers and CMOs to transfer technologies and ensure timelines and budgets are met.

Strong background in radiochemistry and pharma GMP is required, with leadership experience and excellent communication skills.

Competenze

• Minimum of 5 years in a scientific area or PhD equivalent
• Proven project leadership across all phases
• GMP, Validation and Regulatory understanding

Mansioni

• Manage inter functional project plan and budget
• Identify issues and potential bottlenecks and propose options
• Contribute to Radioisotope TRD activities and technological survey
• Participate in development programs aligned with Isotope strategy
• Identify strategic external partners for collaboration and new production tech

Conoscenze

Project leadership

Radioisotope production

Purification/separation

Cross-functional collaboration

Communication

Formazione

BSc in Chemical Engineering

Desirable MSc/PhD in Radiochemistry

Descrizione del lavoro

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).

Summary

Location: Ivrea, Italy #onsite

About The Role

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.
• Represents 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

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Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

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