Senior Director Technical Operations - Radioligand Therapies
Scorpion Therapeutics, New Philadelphia, Pennsylvania, United States, 17959
Role Summary
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 helps shape CMC strategy and decision-making. The role ensures manufacturing, analytical chemistry, and technology transfer activities are scientifically rigorous, compliant, and phase-appropriate, partnering with development teams to drive decisions and accelerate program timelines. 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. Scientific & Technical Leadership
- Demonstrate calm, decisive leadership when challenges arise, using evidence-based reasoning to drive resolution and maintain supply continuity. Scientific & Technical Leadership
- 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. Technology Transfer Leadership
- Drive seamless scale-up and readiness for late-stage clinical manufacturing. Technology Transfer Leadership
- 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. CDMO Oversight
- Serve as the primary scientific and technical point of contact to resolve deviations, supply risks, and complex technical issues at CDMOs. CDMO Oversight
- 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. CMC Governance
- Review and approve GMP documentation (OOS, deviations, change controls) with strong technical judgment. CMC Governance
- Ensure adherence to regulatory requirements and internal quality standard. Operational Excellence
- Develop and implement science-driven strategies to optimize manufacturing processes and analytical methods. Operational Excellence
- Drive continuous improvement initiatives for efficiency and compliance. Operational Excellence
- Create and manage technical operations budgets, including OPEX and CAPEX. Operational Excellence
- 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. Cross-Functional Collaboration
- Influence teams by translating complex technical concepts into clear, actionable recommendations that support development decisions. Cross-Functional Collaboration
- 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. Leadership
- Provide steady, influential leadership that empowers teams and sustains performance through change and ambiguity. Qualifications
Required:
Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field 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 Required:
Willingness and ability to travel globally up to 20% 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
#J-18808-Ljbffr
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 helps shape CMC strategy and decision-making. The role ensures manufacturing, analytical chemistry, and technology transfer activities are scientifically rigorous, compliant, and phase-appropriate, partnering with development teams to drive decisions and accelerate program timelines. 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. Scientific & Technical Leadership
- Demonstrate calm, decisive leadership when challenges arise, using evidence-based reasoning to drive resolution and maintain supply continuity. Scientific & Technical Leadership
- 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. Technology Transfer Leadership
- Drive seamless scale-up and readiness for late-stage clinical manufacturing. Technology Transfer Leadership
- 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. CDMO Oversight
- Serve as the primary scientific and technical point of contact to resolve deviations, supply risks, and complex technical issues at CDMOs. CDMO Oversight
- 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. CMC Governance
- Review and approve GMP documentation (OOS, deviations, change controls) with strong technical judgment. CMC Governance
- Ensure adherence to regulatory requirements and internal quality standard. Operational Excellence
- Develop and implement science-driven strategies to optimize manufacturing processes and analytical methods. Operational Excellence
- Drive continuous improvement initiatives for efficiency and compliance. Operational Excellence
- Create and manage technical operations budgets, including OPEX and CAPEX. Operational Excellence
- 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. Cross-Functional Collaboration
- Influence teams by translating complex technical concepts into clear, actionable recommendations that support development decisions. Cross-Functional Collaboration
- 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. Leadership
- Provide steady, influential leadership that empowers teams and sustains performance through change and ambiguity. Qualifications
Required:
Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field 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 Required:
Willingness and ability to travel globally up to 20% 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
#J-18808-Ljbffr