Head, Isotopes Manufacturing and Supply

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

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.

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