Overview
Location: Basel, Switzerland OR Ivrea, Italy
Isotope Project Lead (IPL) - Associate Director S&T role at Novartis Italia. Role focused on providing specialist knowledge as Subject Matter Expert in radioisotope production and purification, with emphasis on assessing, developing, and optimizing new technologies to support RLT products Life Cycle Management (LCM).
Role Responsibilities
* Develop, optimize and transfer radioisotopes production and purification/separation processes in close collaboration with relevant development centers and Contract Manufacturing Organizations (CMOs).
* Manage inter functional project plan and budget using the Project Planning tool or System.
* Identify issues and potential bottlenecks within projects and propose options.
* Contribute to Radioisotope TRD-related activities. Maintain continuous technological survey in the field of radioisotope production. Apply scientific/technical expertise to identify new programs of interest and support their development from early evaluation through late phase supply.
* Participate in development programs 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 to activate research collaboration agreements to develop new production technologies or access to innovative isotopes.
* Implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
* Establish and ensure adherence to budgets, schedules, work plans, and performance requirements.
* Represent the area as a core member in Global Project Teams for defining global scientific strategy up to submission and approval in major markets for assigned products.
* Report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples where applicable.
Minimum Requirements
* BSc in Chemical Engineering, Pharmaceutical Technology, or equivalent scientific degree.
* Desirable MSc, PhD or equivalent experience.
* Desirable degree in Radiochemistry with strong knowledge in nuclear medicine.
* 5+ years of directly related scientific experience (or PhD/equivalent).
* Proven Project Leadership across all project phases.
* Proven understanding of Pharma, GMP, Validation and Regulatory aspects.
* Strong data handling and applied statistics experience.
* Strong understanding of risk assessment and risk management fundamentals/tools.
* Quality-oriented with attention to detail.
* Excellent verbal and written communication skills; strong problem solving and decision-making abilities.
* Ability to define and implement productivity improvement measures.
Commitment to Diversity and Inclusion: Novartis is committed to building an inclusive work environment with diverse teams representative of the patients and communities we serve.
Accessibility and accommodation: Novartis provides reasonable accommodation to all individuals in recruitment or to learn about essential functions of the position. Please email inclusion.switzerland@novartis.com with your request and include the job requisition number.
Why Novartis: Helping people with disease and their families requires more than innovative science. It takes a community of smart, passionate people. Collaboration, support, and inspiration lead to breakthroughs that change patients’ lives. Learn more: https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Consulting, Information Technology, and Sales
Industries
* Pharmaceutical Manufacturing
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