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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.

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. This position will provide technical expertise and leadership to support Avid's drug development program.

The Advisor/Technical Lead is responsible for providing technical expertise and leadership to independently contribute to all aspects of analytical development within the Analytical Development and Quality Control group in support of Avid’s drug development program. The individual is expected to participate on project teams and collaborate with researchers within the same discipline and across other functional groups/departments.

Responsibilities:

• Provide scientific leadership throughout the Analytical Development and Quality Control group and acquire new analytical knowledge and capabilities that are needed to support novel research projects.

• ndependently develop and validate analytical methods for precursors, reference standards, and drug products in support of product development and commercial manufacturing based on HPLC and GC and other needed techniques.

• Write and review study protocols and reports in support of research studies and method validation. Execute studies independently according to company priorities and deliverables to meet project timelines.

• Build a diverse cross-functional internal network and stay current with external scientific developments related to both analytical chemistry and radiopharmaceuticals and share knowledge with the Analytical Development and Quality Control group.

• Support regulatory submissions with high quality analytical documentation by preparing and providing source and specific information for the CMC section.

• Provide on-site support for studies at CMO sites within the US and internationally (e.g. analytical technology transfer, stability studies, studies contracted to CRO’s) as required and provide troubleshooting support for analytical method or drug product issues, as needed.

• Support release and stability testing for clinical trial materials, commercial products, and excipients at Avid and through contract manufacturing organizations.

Basic Requirements:

• Bachelors degree in chemistry or a related field with at least 10 years of experience, or Masters degree with a minimum of 5 years of experience, or Ph.D. degree with minimum of 2 years of experience in pharmaceutical analytical development.

Additional Skills/Preferences:

• Thorough knowledge of cGMPs, ICH Quality guidance, FDA and international CMC guidance's.

• Extensive knowledge and experience in analytical separation techniques and method development/validation for pharmaceutical products.

• Ability to manage multiple and competing priorities through effective organizational and time management skills.

• Excellent written and verbal communication skills.

• Demonstrated ability to work independently in a highly focused manner.

• Familiarity with radiochemistry desirable but not required.

Additional Information:

• Ability to travel within the US and internationally 0-25% of the time.

• Position is located in Philadelphia, PA.

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