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.

Organization and Position Overview:

• Lilly is seeking a Principal Scientist
• Analytical Chemistry based in Toronto, ON to support the development of its clinical-stage radiopharmaceutical assets. The successful candidate will lead analytical method development and validation activities to support radiopharmaceutical manufacturing, technology transfer, and regulatory submissions across early clinical development.

This is an ideal role for an analytical chemist with hands-on experience in radiopharmaceutical analysis and GMP environments, who thrives in a fast-paced, matrix-managed organization and is motivated to contribute to the development of next-generation radioligand therapies while ensuring a safe and compliant laboratory environment.

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.
• Prepare and deliver verbal and written reports, method feasibility reports, and presentations to internal and external stakeholders.
• Monitor project timelines, identify risks, and propose mitigation strategies to meet development milestones.
• Participate in the optimization, streamlining, and scale-up of analytical methods in preparation for clinical and commercial supply.

Basic Requirements:

• 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.

Additional Preferences:

• Master's degree in chemistry, analytical chemistry or a related discipline, with 2+ years of relevant industry experience in analytical development, method validation, and/or testing within a GMP-regulated environment.
• Experience with radiopharmaceutical testing is strongly preferred.
• Hands-on experience with PET and/or theranostic radioisotopes (e.g., F-18, Ga-68, Cu-64, Lu-177, Ac-225, Tb-161).
• Experience working with external partners, vendors, and CDMOs.
• Ability to adapt and shift priorities as needed or requested, along with the understanding that asking questions is encouraged.
• Willingness to travel up to 20% (but likely less) within North America and internationally; valid passport required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$ - $

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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