Advisor, Analytical Chemistry

Lilly • Indianapolis, IN

2d • $126,000 - $204,600

About The Position

The Advisor, Analytical Chemist is a technical role within Lilly’s Radiopharmaceuticals (RLT) Chemistry, Manufacturing & Controls (CM&C) Technical Operations function. Reporting to the Senior Director, Technical Operations, the position leads analytical method transfer, development, optimization, and validation for phase 1b through phase 3 radiopharmaceutical programs. The Advisor is the primary analytical chemistry subject matter expert and develops scientifically sound, phase-appropriate method strategies that meet GMP, ICH, USP, and regulatory expectations.

The role works across analytical science, regulatory compliance, and program delivery, partnering with QC, CMC Regulatory, manufacturing, and external CDMOs. It supports analytical readiness for late-phase development milestones and regulatory submissions, with responsibilities spanning method development and validation, regulatory documentation, GMP quality and compliance, and cross-functional collaboration.

The position is Monday through Friday during standard business hours, with periodic off-hours responsiveness potentially required to support GMP manufacturing or regulatory timelines. Standard PPE and radiological safety protocols apply in RLT manufacturing and laboratory areas. Estimated travel is 5–15% domestically and internationally; a valid passport and eligibility to travel within North America and Europe are required. The anticipated wage is $126,000–$204,600. Eligible full-time employees may receive a company bonus and access to benefits including a 401(k), pension, vacation, medical, dental, vision and prescription drug benefits, flexible spending accounts, life insurance, leave benefits, and well-being benefits.

Requirements

• Bachelor’s degree in chemistry, analytical chemistry, or organic chemistry.
• 10 or more years of relevant experience in analytical development, analytical validation, and/or analytical testing in a GMP setting.
• Demonstrated expertise developing and conducting full ICH Q2(R2)-compliant validation of chromatographic methods (HPLC, UPLC, GC, TLC) and spectroscopic methods (MS, UV/Vis, gamma).
• Functional knowledge of GMP regulations and applicable FDA, EMA, ICH, USP, and PDA guidelines relevant to analytical testing.
• Ability to work effectively in a cross-functional environment, with strong project management and organizational skills.
• Proficiency with analytical data systems and laboratory informatics, such as Empower, Chromeleon, and MassLynx.
• Strong oral and written communication skills, including the ability to present technical data to diverse audiences, including senior leadership and regulatory agencies.
• Periodic off-hours responsiveness may be required in support of GMP manufacturing or regulatory timelines.
• A valid passport and eligibility to travel within North America and Europe are required.

Nice To Haves

• Master’s degree in a chemistry field with 5 or more years of relevant experience, or a PhD in a chemistry field with 2 or more years of relevant experience.
• Hands-on experience in the biotech or pharmaceutical industry.
• Experience with radiopharmaceutical analytical testing, including HPLC with radiometric detection, radiometric TLC, and gamma spectroscopy for PET (F-18) and/or theranostic radioisotopes (Lu-177, Ac-225).
• Hands-on experience authoring CMC regulatory submissions and method validation packages for late-phase (Phase 3) or commercial programs.
• Experience with CDMO/external partner analytical qualification and method transfer in a GMP context.
• Familiarity with regulatory expectations for late-phase radiopharmaceutical analytical control strategies, including ICH Q14 and ICH Q8/Q9/Q10 pharmaceutical quality system principles.

Responsibilities

• Lead design, development, and optimization of analytical methods for radiopharmaceutical APIs and drug products, including small molecules, peptides, and radiolabeled compounds.
• Develop and optimize chromatographic methods such as HPLC, UPLC, TLC, and GC, and spectroscopic methods such as gamma spectroscopy, mass spectrometry, UV/Vis, and NMR, as appropriate for late-phase programs.
• Apply phase-appropriate development strategies aligned with ICH Q14, ICH Q2(R2), and applicable USP/EP compendial requirements.
• Identify and implement analytical technology improvements and method modernization initiatives; troubleshoot complex method performance issues and implement robust, validated solutions.
• Author method validation protocols and reports in compliance with ICH Q2(R2), USP <1225>, and applicable regulatory guidance.
• Lead analytical method qualification and validation at internal sites and external CDMOs or partners.
• Perform or oversee transfer of validated methods to QC release and stability testing laboratories; prepare and review transfer protocols, comparability studies, and qualification and validation reports.
• Ensure validation data packages are complete, defensible, and ready for regulatory submission.
• Author analytical sections of CMC regulatory submissions, including INDs, CTAs, NDA/BLA, and MAA materials, method descriptions, validation summaries, and specification justifications.
• Develop and justify release and stability specifications for starting materials, intermediates, and drug products with CMC Regulatory and QA.
• Prepare responses to regulatory agency inquiries regarding analytical methods and specifications.
• Author and review standard test methods, SOPs, change controls, and technical reports in accordance with GMP and Good Documentation Practices.
• Support internal and external GMP audits by providing analytical expertise.
• Ensure analytical activities comply with cGMP, cGLP, applicable FDA, EMA, Health Canada, ICH, USP, PDA, and Lilly quality standards.
• Review and approve experimental data from internal laboratories and external CDMOs/vendors; interpret results and document conclusions.
• Lead or support investigations of OOS results, analytical deviations, and aberrant data using robust root cause analysis.
• Serve as the analytical chemistry SME for late-phase RLT programs and provide technical direction to cross-functional CMC teams.
• Build and maintain productive relationships with internal and external CDMOs, analytical service providers, and regulatory partners.
• Collaborate with QC, CMC Regulatory, Manufacturing Sciences, and Supply Chain to ensure analytical readiness for clinical and commercial supply.
• Represent analytical capabilities in project team meetings, technical reviews, and governance forums.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• Prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior