Summary
Location: Basel, Switzerland OR Ivrea, Italy
Role
Isotope Project Lead (Associate Director S&T) role at Novartis – act as Subject Matter Expert (SME) of radioisotope production and purification, with 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 in close collaboration with relevant development centers and Contract Manufacturing Organizations (CMOs).
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 propose 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 to late phase supply.
* Participate in 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 activation of research collaboration agreements to develop new production technologies/access to innovative isotopes.
* Implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
* Establish budgets, schedules, work plans, and performance requirements and ensure adherence.
* Represent area as a core member in Global Project Teams for defining global scientific strategy for development up to submission and approval in major markets of assigned product(s).
* 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 and strong scientific knowledge in nuclear medicine.
* Several years of directly related experience in a scientific area (minimum 5 years) or PhD 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.
* 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.
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.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Consulting, Information Technology, and Sales
Industries
* Pharmaceutical Manufacturing
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