Senior Director Technical Operations - Radioligand Therapies
Scorpion Therapeutics, Indianapolis, Indiana, us, 46262
Role Summary
Senior Director of Technical Operations, Radioligand Therapies. Location: Indianapolis, Indiana. Leads scientific and technical execution across Radioligand Therapy programs, guiding teams through complex development and manufacturing challenges, and ensuring robust CDMO collaboration and manufacturing readiness. Shapes CMC strategy and decision-making to accelerate program timelines. Travel up to 20% may be required. Responsibilities
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. 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. 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. 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. 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. 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. 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. 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. Qualifications
Required: 10+ years of experience in technical operations within the pharmaceutical or radiopharmaceutical industry Required: Proven expertise in GMP, CMC regulatory requirements, and CDMO tech transfer Required: Strong scientific leadership and vendor-management skills Required: Excellent communication and problem-solving abilities; creative thinking and ability to cultivate innovation Required: Familiarity with global regulatory frameworks (FDA, EMA, ICH) Required: Legally authorized to be employed in the United States or Canada Preferred: Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Preferred: Experience with radioligand therapy or complex drug modalities Preferred: Ability to manage multiple projects in a fast-paced environment Preferred: Demonstrated ability to lead through ambiguity and drive engagement among teams Preferred: Ability to adapt to change and be a nimble learner Education
Required: Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Preferred: Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Additional Requirements
Willingness and ability to travel globally up to 20%
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Senior Director of Technical Operations, Radioligand Therapies. Location: Indianapolis, Indiana. Leads scientific and technical execution across Radioligand Therapy programs, guiding teams through complex development and manufacturing challenges, and ensuring robust CDMO collaboration and manufacturing readiness. Shapes CMC strategy and decision-making to accelerate program timelines. Travel up to 20% may be required. Responsibilities
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. 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. 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. 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. 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. 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. 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. 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. Qualifications
Required: 10+ years of experience in technical operations within the pharmaceutical or radiopharmaceutical industry Required: Proven expertise in GMP, CMC regulatory requirements, and CDMO tech transfer Required: Strong scientific leadership and vendor-management skills Required: Excellent communication and problem-solving abilities; creative thinking and ability to cultivate innovation Required: Familiarity with global regulatory frameworks (FDA, EMA, ICH) Required: Legally authorized to be employed in the United States or Canada Preferred: Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Preferred: Experience with radioligand therapy or complex drug modalities Preferred: Ability to manage multiple projects in a fast-paced environment Preferred: Demonstrated ability to lead through ambiguity and drive engagement among teams Preferred: Ability to adapt to change and be a nimble learner Education
Required: Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Preferred: Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field Additional Requirements
Willingness and ability to travel globally up to 20%
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