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.

JOB DESCRIPTION:

The Chemist / Sr. Chemist / Principal Chemist, role is focused on the quality control testing of the various radiopharmaceutical products manufactured at the Lilly CORE site. All testing performed is in accordance with the established drug product and API release specifications. Perform technical transfers, development, and validation of analytical test methods associated with finished dosage form (FDF) drug products and API radioisotope products. Deliver investigation, resolution, and mitigation of deviations, non-conformances, and OOS (Out of Specification) events associated with products tested at the Lilly CORE facility.

BASIC QUALIFICATIONS:

• Bachelor’s degree in chemistry or related field
• 3+ years of relevant industry experience in analytical laboratories is required (including experience in analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, HPLC analytical testing, method development, and method validation)

• Conduct chemical and physical testing of raw materials, API, in-process, radioactive finished products, and stability samples, using established test methods to provide accurate and reliable data to assure their strength, identity and purity.
• Work with radioactive materials using safe protocols to maintain ALARA.
• Maintaining accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.
• Recording and reporting results of analysis in accordance with approved lab procedures, standard test methods and systems.
• Participating in and contributing to the maintenance and calibration of analytical instruments within the quality control laboratories.
• Collaborating with TS/MS, QA/CMC and Regulatory colleagues to establish release and stability specifications for starting materials, intermediates, drug substances, and drug products.
• Adhering to all applicable procedures, cGLP, cGMP, company policies and any other quality or regulatory requirements.
• Working well in a fast-paced team environment.
• Collaborate with management to identify training needs and ensure appropriateness of training plans, creating and assigning curricula as required.
• Contribute to the training, education, guidance, and influence of operational and support areas on quality control policy and practices.
• Fosters a culture of collaboration, partnership, teamwork, and a drive for change and continuous improvement
• Perform other duties as assigned