Sr. Director - CMC Development

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 35,000 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.

Organization Overview:

Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare.

Responsibilities:

This position has overall responsibility for Avid's global investigational medicinal product (IMP) manufacturing, IMP and commercial product precursor contract manufacturing and provides leadership and direction to IMP Manufacturing Operations, and Supply Chain operations teams. The individual will provide expertise and leadership in the development and manufacturing of new radiopharmaceutical products working in a fast-paced, multi-disciplinary environment.

• Lead and direct the establishment and operation of Avid's just-in-time manufacturing of PET radiopharmaceutical investigational medicinal product (IMP) at contract manufacturing organizations (CMO) globally to ensure reliable and sufficient supply to Avid/Lilly clinical trials.
• Provide leadership and direction to IMP Manufacturing Operationsand Supply Chain Operations functions and teams
• Oversee the management of IMP and commercial product precursor and reference standard contract manufacturing to support global operations.
• Oversee Supply Chain Operations supporting global IMPand Radiopharmaceutical Commercial Manufacturing
• Partner with key functions (e.g. Clinical Supply, Clinical Development, Clinical Operations, and Clinical Imaging Operations) in the planning and execution of a manufacturing strategy to meet clinical trial supply requirements.
• Assess and approve GMP change controls (globally) with respect to technical impact.
• Direct planning for and monitoring of the CMC Development budget.
• Lead other tasks / projects as assigned

Basic Requirements:

• Bachelor's degree in Chemistry or related field
• Minimum of 8 years of pharmaceutical industry experience

Additional Skills/Preferences:

• PET drug experience preferred
• Ability to lead and direct teams of scientists and operational staff in the successful execution of complex drug development and supply projects and programs
• Advanced understanding of cGMPs and CMC regulatory requirements
• Ability to manage people and drive engagement among teams
• Ability to adapt to change and be a nimble learner
• Ability to ensure accountability of oneself and others
• Ability to plan and align
• Creative thinking and ability to cultivate innovation
• Impeccable organizational skills
• Superior written and verbal communication skills
• Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)

Additional Information:

• Must be willing and able to travel within the USA and worldwide 20% of time.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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