About The Position

This senior role leads the end-to-end manufacturing strategy and operations for a radiopharmaceutical portfolio. The primary focus is on matching global demand with dependable supply, ensuring quality and compliance, and optimizing cost and service across a highly regulated chain. The work directly enables patient access to targeted therapies by ensuring on-time production, right-first-time performance, and time-definite delivery. The role involves shaping a global network of internal sites and external partners, building digital capabilities for improved forecast accuracy and response, and leading a cross-functional organization focused on continuous improvement and patient impact. This is a global role with significant international travel. While the advertised location is Gaithersburg, US, flexibility is offered, and other US and international locations will be considered.

Requirements

  • 15+ years in pharmaceutical manufacturing or supply chain, including 8+ years in senior global leadership.
  • Direct experience in radiopharmaceuticals or nuclear medicine operations strongly preferred (e.g., PET/SPECT isotopes, cyclotron/reactor supply, radiolabeling, aseptic operations).
  • Deep understanding of GMP, aseptic processing, radiolabeling, cold chain logistics, and dangerous goods regulations.
  • Proven track record in S&OP/IBP, capacity planning, and network strategy.
  • Demonstrated success navigating global regulatory requirements, inspections, and quality systems; strong partnership with QA/RA to maintain compliance and support submissions/variations.
  • Experience leading external manufacturing networks and complex supplier relationships, including contract negotiation and performance management.
  • Proficiency with advanced planning systems, demand forecasting, and operations analytics; ability to leverage data to drive decision-making and continuous improvement.
  • Exceptional people leadership, stakeholder management, and change management skills; adept at influencing across R&D, Commercial, Finance, and Operations.
  • Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field required.

Nice To Haves

  • Advanced degree (MS/MBA/PhD) strongly preferred.
  • Lean and Six Sigma certification with a record of deploying continuous improvement and digital operations in GMP environments.
  • Proven success launching and scaling radiopharmaceutical products across multiple regions, including label/pack variation readiness and market-specific configurations.
  • Experience negotiating and operationalizing CDMO/CMO capacity guarantees, risk-sharing models, and business continuity clauses.
  • Deep expertise in time-definite, cold-chain logistics for dangerous goods, including courier network optimization and final mile orchestration.
  • Experience implementing IBP/S&OP, demand sensing, and predictive analytics across a global manufacturing network.
  • Track record of building and leading high-performing, geographically dispersed teams through growth and change.

Responsibilities

  • Design and maintain a resilient global manufacturing network across internal sites and CDMOs/CMOs, including aseptic fill-finish, labeling, and final mile logistics; develop short-, medium-, and long-term capacity models aligned to portfolio growth and lifecycle events to ensure supply readiness.
  • Drive right-first-time performance, yield improvement, and cycle-time reduction using Lean, Six Sigma, and digital operations; establish KPIs and tiered governance to monitor OTIF, service levels, cost-to-serve, and scrap/waste—translating insights into actions that lift productivity and reliability.
  • Own the S&OP/IBP cadence for radiopharmaceuticals; translate global demand forecasts into executable production plans, capacity commitments, and inventory targets across internal and external nodes to protect patient schedules and market commitments.
  • Partner with QA and Regulatory to assure GMP compliance globally; maintain validated processes, robust batch release, inspection readiness, and controlled tech transfers and changes without supply disruption.
  • Lead manufacturing readiness for new launches and indication expansions; scale capacity on time, manage label/pack variations, and configure markets while planning for demand volatility and radiolabel half-life constraints.
  • Negotiate and manage CDMO/CMO agreements with clear capacity guarantees and business continuity provisions; assess and onboard new partners to strengthen geographic coverage and diversify risk.
  • Orchestrate just-in-time distribution for time- and temperature-sensitive materials, ensuring cold chain integrity, dangerous goods compliance, and time-definite delivery; optimize routing, hubs, and courier networks to meet half-life windows and patient appointments.
  • Build proactive risk management for reactor outages, isotope shortages, geopolitical events, and transport disruptions; maintain dual-sourcing, safety stock strategies, and contingency playbooks tied to demand signals.
  • Implement digital planning tools, demand sensing, and predictive analytics to improve forecast accuracy and supply responsiveness; enable real-time visibility from isotope production through patient administration.
  • Own manufacturing budgets, COGS optimization, and capital investments in capacity and technology; deliver productivity targets while continuously improving service and quality.
  • Lead a global, cross-functional organization spanning manufacturing, planning, tech ops, logistics, and external manufacturing; foster a culture of safety, quality, continuous improvement, accountability, and patient focus.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program (salaried roles)
  • Retirement contribution (hourly roles)
  • Commission payment eligibility (sales roles)
  • Qualified retirement program [401(k) plan]
  • Paid vacation and holidays
  • Paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage
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