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Location: Indianapolis, Indiana, USA or Baarlé Nassau, Netherlands. This is an on-site role. At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced manufacturing and supply leader to help us reach our ambitious goals. As the Head of Isotopes Manufacturing and Supply Operations, you will lead all activities related to isotopes sourcing, supply (external and internal), and internal isotopes manufacturing activities for the Radioligand (RLT) Platform. You will be responsible for establishing short, mid, and long-term strategies to ensure all commercial RLT products are sustainably and reliably supplied in accordance with Novartis development and commercial plans. This role will report to the Global Head RLT Technical Operations and be part of the Global RLT Technical Operations Leadership Team.
About The Role
Key Responsibilities:
From the Technical Operations (TechOps) perspective, own the sourcing and manufacturing of precursor isotopes and irradiation strategies for short, mid, and long-term. Secure supply for the next 10 years.
Serve as key TechOps leader interfacing and leading a matrix collaboration with commercial isotopes suppliers
Identify new potential suppliers and strategic alliances in conjunction with the Technical Research and Development (TRD), Business Development, (B&D) and/or Mergers and Acquisitions (M&A) functions.
Oversee the manufacturing operations at the Baarle-Nassau Site, Netherlands, and future Lu NCA in Indianapolis, USA, as well the external isotopes suppliers.
Ensure the new Lu NCA facility in Indianapolis comes on-line per the projected investment Plan and cost optimization plans.
Establish commercial supply for the next generation of isotopes.
Essential Requirements
BSc degree in engineering or related field or equivalent relevant experience
15 years of Operations leadership of US/ EMEA cGMP manufacturing operations. API and sterile drug product experience is preferred.
Experience with major Capital Investment Projects and new plant qualification and start-up
Prior experience in engineering and maintenance of a cGMP plant, including design of facilities according to Lean concepts in material, people, and waste flows, preferably in aseptic manufacturing and radiopharmaceutical processing
Direct involvement with quality regulatory inspections of facilities from major agencies such FDA or EMA
Understanding of Radiation Safety regulations in the markets where Novartis has Operations of Lu NCA manufacturing (US, EMEA)
Significant Environment Health and Safety, and GxP / QA experience building an injury and error-free culture with knowledge of multiple compliance areas (corporate governance, financial, quality, environment, safety)
English fluency required
Desirable Requirements
Proven experience in the precursor isotopes market/ dynamics is highly preferred.
Training in radiochemistry, radio pharmacy and/or Radioprotection is an advantage.
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: novartis-life-handbook.pdf.
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.
The pay range for this position at commencement of employment is expected to be between $222,400 and $333,600 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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
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EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Seniority level
Executive
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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