James Avenell

· Oversee manufacturing operations in the USA, CA and EU, Netherlands, and future Lu 177 production line in Indianapolis, as well the external isotopes suppliers.

· manufacturing of precursor isotopes and irradiation strategies for short, mid, and long-term. Identify new potential suppliers and strategic alliances in conjunction with the Technical Research and Development.

Manufacturing and collaborating closely with the Manager of Logistics, the Sr. Manager of Isotope Development and Supply will oversee the vertical integration of Eli Lilly`s radioisotope supply chain to produce radioligand therapies while ensuring the Isotope manufacturing teams is assembled, trained, and ready for production related responsibilities. The Associate Director of Isotope Development and Supply will operate in a just-in-time production model and will have functional responsibility.

• Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
• Prioritized tasks and allocated resources appropriately to keep teams focused and productive.
• Assisted senior leadership in managing all aspects of operations.
• Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints.
• Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
• Mentored junior staff members, providing guidance on professional development opportunities and career progression paths within the company.
• Established strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration.
• Implemented data-driven decision-making strategies, leading to more informed business choices and positive outcomes.
• Improved overall team efficiency by streamlining project management processes and implementing new collaboration tools.
• Maintained compliance with industry regulations while adapting to changes in legislation or best practices as needed.
• Defined clear targets and objectives and communicated to other team members.
• Launched quality assurance practices for each phase of development
• Identified and communicated customer needs to supply chain capacity and quality teams.

• Developed, chartered and lead Production Excellence team for DOE isotope production lines. Including isotope but not limited to, Ac 227, Ac 225, Rad 226, Th 228, Pb 212.
• Generated detailed reports on production performance metrics, facilitating informed decision-making by management.
• Inspected products and machines to maintain quality and efficiency.
• Enhanced workplace safety by conducting thorough risk assessments and implementing necessary precautions.
• Organized work to meet demanding production goals.
• Worked with supervisors and team members to understand supply needs and bring levels within desired tolerances.
• Addressed supply problems and developed creative solutions to prevent delays.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Calibrated machines to maintain required productivity levels and adherence to quality standards.
• Performed general equipment maintenance and repair to minimize downtime.
• Prepared reports and technical documentation of day-to-day production processes.
• Improved production efficiency by implementing Lean Manufacturing principles and streamlining processes.
• Reviewed production schedules and streamlined processes.

• Generated detailed reports on production performance metrics, facilitating informed decision-making by management.
• Inspected products and machines to maintain quality and efficiency.
• Enhanced workplace safety by conducting thorough risk assessments and implementing necessary precautions.
• Organized work to meet demanding production goals.
• Worked with supervisors and team members to understand supply needs and bring levels within desired tolerances.
• Addressed supply problems and developed creative solutions to prevent delays.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Calibrated machines to maintain required productivity levels and adherence to quality standards.
• Performed general equipment maintenance and repair to minimize downtime.
• Prepared reports and technical documentation of day-to-day production processes.
• Improved production efficiency by implementing Lean Manufacturing principles and streamlining processes.
• Reviewed blueprints and job specifications to plan completion and estimate project costs.
• Participated in quality assurance audits as needed, verifying compliance with established procedures and regulations.
• Implemented continuous improvement initiatives to increase overall efficiency and reduce waste in the production process.
• Worked closely with engineering teams to troubleshoot equipment issues, identify root causes, and develop timely solutions.
• Trained new employees on manufacturing processes, equipment operation, and company policies, fostering a skilled workforce.
• Assisted in the implementation of new manufacturing technologies or systems, ensuring seamless integration with existing processes and minimal disruptions to production schedules.
• Reduced equipment downtime by performing regular maintenance checks and coordinating repairs with technicians.
• Developed strong relationships with suppliers, negotiating favorable terms for raw materials procurement while maintaining high quality standards.
• Maintained accurate records of all production activities, including material usage, equipment maintenance logs, and employee attendance tracking sheets.
• Collaborated with cross-functional teams to develop new products that met customer requirements and market demands.
• Conducted root cause analysis for production issues, providing effective solutions to minimize recurrence of problems.
• Identified problems and specific resolutions to fix defective, damaged, or malfunctioning parts, assemblies, equipment and systems.
• Reviewed products for compliance with Design for Manufacturing (DFM) requirements.
• Served as technical liaison between customer, manufacturing, quality assurance and vendor and supplier personnel to resolve technical and quality issues.
• Supervised product development and introduction of prototypes for radiochemical separation designs.
• Developed automation tools to improve efficiency, eliminate waste and free up labor hours for other needs.
• Managed quality assurance initiatives.
• Mapped process workflows to enhance understanding of procedures.
• Generated, submitted and presented reports to enhance emission release quality standards.
• Investigated processes to develop maps and determine optimal improvement approaches.

• Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
• Contributed to successful FDA approval of new medical devices through diligent management of investigational studies.
• Expedited final data analysis by working closely with biostatisticians to ensure clean datasets were prepared for statistical evaluation.
• Advocated for patient interests by serving on institutional review boards, helping to ensure the ethical treatment of research participants.
• Promoted a culture of ethical conduct within the research team by stressing the importance of informed consent and adherence to good clinical practice guidelines.
• Ensured regulatory compliance by maintaining up-to-date knowledge of industry standards and guidelines.
• Facilitated effective communication between clinical sites, sponsors, and CROs, ensuring timely resolution of issues that arose during trial execution.
• Collaborated with cross-functional teams to design, implement, and evaluate clinical research protocols.
• Managed budgets and timelines for multiple concurrent studies, ensuring resource allocation aligned with project goals.
• Assisted principal investigators in preparing grant proposals, securing funding for critical research projects.
• Assisted with analysis of research data in collaboration with research department.
• Advanced scientific understanding by authoring manuscripts detailing study findings for publication in peer-reviewed journals.

• Startup and development of Pre-clinical diagnostic imaging lab
• Radio tracer development for clinical trials.
• Ensured safety standards were maintained by properly handling radioactive materials during procedures.
• Educated patients on procedure details, provided instructions, and answered questions to minimize anxiety and improve cooperation.
• Produced diagnostic images for use in identification and treatment of diseases by applying and measuring radioactive isotopes.
• Contributed to increased department efficiency by maintaining the cleanliness and organization of equipment and workspace.
• Enhanced patient care by performing accurate and efficient diagnostic imaging studies.
• Developed and implemented improved diagnostic standards for inpatient and outpatient exams in alignment with department goals.
• Conducted routine inspections of radiopharmaceuticals inventory, ensuring proper storage conditions to prevent contamination or degradation.
• Demonstrated commitment to patient privacy by adhering to HIPAA regulations throughout all aspects of nuclear medicine procedures and communications.
• Kept current on industry advancements through regular attendance at continuing education conferences and workshops.