Isotope Project Lead (Associate Director S&T)

Novartis; Ivrea; On-site; EUR 120,000 - 170,000; Full time

Job summary

Novartis in Ivrea, Italy is seeking an Isotope Project Lead (IPL) to provide SME expertise in radioisotope production and purification, and to drive development and optimization of new technologies for LCM of RLT products.

The role involves leading cross-functional programs, collaborating with development centers and CMOs, and ensuring timely delivery within budget and global isotope strategies.

Qualifications

• Minimum 5 years of directly related experience.
• Experience with Pharma GMP and regulatory aspects.
• Italian language required as site language.
• Strong problem solving and decision making.

Responsibilities

• Lead inter-functional project plans and budgets.
• Identify issues and bottlenecks and propose options.
• Advance isotopes production and purification technologies.
• Coordinate with development centers and CMOs.
• Report progress and challenges to leadership.

Skills

Project leadership

Communication skills

Risk management

Data analysis

Education

Bachelor's degree in Chemical Engineering

Desirable MSc./PhD in Radiochemistry

Tools

Project Planning tool

Job description

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).

Job Description

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

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.