About the role

Principal Scientist leading analytical method development and validation for clinical-stage radiopharmaceuticals at Lilly. Ensuring compliance with industry standards and managing laboratory studies efficiently.

Responsibilities

Carry out analytical laboratory studies with radiopharmaceuticals, including method development, validation, and sample analysis, for bulk material, vials, peptides, or peptide–radioactive conjugates, ensuring strict adherence to cGLP and cGMP requirements.
Develop, author, and maintain analytical test methods, method validation protocols and reports, following USP, EP, and ICH guidelines.
Execute method validation and feasibility studies with precision, accuracy, and reproducibility, maintaining high-quality records of all experimental work.
Review and interpret experimental data generated internally and by external vendors/partners; summarize results in comprehensive, clear, and regulatory-compliant documentation.
Lead technology transfer of analytical methods to external CDMOs, ensuring all procedures, instructions, and reports are complete, accurate, and compliant.
Partner with Quality teams to review manufacturing and analytical data, conduct trending, and ensure compliance with internal and regulatory standards.
Maintain a safe laboratory environment, strictly following radiation safety protocols, SOPs, and best practices for working with isotopes.
Promote safety awareness among all team members.

Bachelor's degree in chemistry, analytical chemistry or a related discipline, with 3+ years of relevant industry experience in analytical development, method validation, and/or testing within a GMP-regulated environment.
Strong hands-on experience with modern analytical techniques, including TLC, HPLC/UPLC, GC, NMR, and mass spectrometry.
Strong knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH, and PDA guidelines.
Demonstrated ability to work independently with strong organizational, communication, and collaboration skills in a matrix environment.

eligibility to participate in a pension plan
vacation benefits
eligibility for healthcare benefits
flexible benefits (if applicable) life insurance and death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)