Senior Director Technical Operations - Radioligand Therapies

Eli Lilly and Company • Indianapolis, IN

1d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization and Position Summary: The CMC Radiopharmaceutical (RP) Development team leads the development and control strategy, including technical oversight and manufacturing readiness for RP assets from portfolio entry through global submissions, approvals, and launch. The Senior Director of Technical Operations provides deep scientific and technical leadership across Radioligand Therapy (RLT) programs, guiding teams through complex development and manufacturing challenges and ensuring robust execution at external CDMOs. This role drives clarity and alignment through ambiguity, provides strong scientific judgment when issues arise, and plays a critical role in shaping CMC strategy and decision‑making. The Senior Director ensures manufacturing, analytical chemistry, and technology transfer activities are scientifically rigorous, compliant, and phase‑appropriate, partnering closely with development teams to drive decisions and outcomes that accelerate program timelines.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field
• 10+ years of experience in technical operations within the pharmaceutical or radiopharmaceutical industry
• Proven expertise in GMP, CMC regulatory requirements, and CDMO tech transfer
• Strong scientific leadership and vendor‑management skills
• Excellent communication and problem‑solving abilities; creative thinking and ability to cultivate innovation
• Familiarity with global regulatory frameworks (FDA, EMA, ICH)
• Legally authorized to be employed in the United States or Canada
• Willingness and ability to travel globally up to 20%

Nice To Haves

• Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field
• Experience with radioligand therapy or complex drug modalities
• Ability to manage multiple projects in a fast‑paced environment
• Demonstrated ability to lead through ambiguity and drive engagement among teams
• Ability to adapt to change and be a nimble learner

Responsibilities

• Scientific & Technical Leadership Serve as the primary technical authority for RLT manufacturing and analytical topics, applying deep scientific rigor to guide teams through complexity. Demonstrate calm, decisive leadership when challenges arise, using evidence‑based reasoning to drive resolution and maintain supply continuity.
• Influence strategy and decision‑making by providing clear scientific rationale, shaping development approaches, and ensuring teams are aligned on technical priorities.
• Technology Transfer Leadership Lead all aspects of technology transfer for drug substance and drug product, ensuring analytical methods, process design, and validation strategies are scientifically robust and phase-appropriate. Drive seamless scale-up and readiness for late-stage clinical manufacturing. Guide teams through technical ambiguity—diagnosing root causes, developing solutions, and aligning internal and external partners on clear paths forward.
• CDMO Oversight Identify, establish, and maintain strong technical partnerships with CDMOs for manufacturing and analytical services. Serve as the primary scientific and technical point of contact to resolve deviations, supply risks, and complex technical issues at CDMOs. Define and monitor metrics to ensure external manufacturing reliability and proactive risk mitigation for global RLT supply.
• CMC Governance Partner closely with CMC development and translational radiochemistry teams to proactively identify and resolve scientific and operational challenges. Review and approve GMP documentation (OOS, deviations, change controls) with strong technical judgment. Ensure adherence to regulatory requirements and internal quality standard.
• Operational Excellence Develop and implement science‑driven strategies to optimize manufacturing processes and analytical methods. Drive continuous improvement initiatives for efficiency and compliance. Create and manage technical operations budgets, including OPEX and CAPEX. Oversee global technical operations including new manufacturing site qualification, technical troubleshooting, manufacturing procedure alignment, and management of Lilly‑owned equipment at contract sites.
• Cross‑Functional Collaboration Partner with discovery, development, clinical, regulatory, and supply chain teams to shape program strategy, integrate scientific insights, and drive timely decision-making. Influence teams by translating complex technical concepts into clear, actionable recommendations that support development decisions. Support regulatory submissions with high‑quality technical content and scientifically sound responses.
• Risk Management Anticipate, identify, and mitigate scientific, technical, operational, and supply chain risks across the RLT manufacturing network. Lead stakeholders through complexity by aligning on mitigation plans and enabling data‑driven decisions under uncertainty.
• Leadership Develop and mentor talent, fostering a culture of scientific excellence, accountability, and continuous improvement. Provide steady, influential leadership that empowers teams and sustains performance through change and ambiguity.

Benefits

• Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level