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Organization Overview:
At Lilly, we serve an extraordinary purpose - we make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. The Radiopharmaceuticals (RLT) Chemistry, Manufacturing & Controls (CM&C) group is at the forefront of advancing therapeutic radiopharmaceuticals from clinical development through commercial launch.
Position Overview:
The Advisor, Analytical Chemist is a critical technical role within the RLT CM&C Technical Operations function. Reporting to the Senior Director, Technical Operations, this position leads the technical transfer, development, optimization, and validation of analytical methods to support phase 1b to phase 3 radiopharmaceutical programs. The Advisor serves as the primary analytical chemistry subject matter expert (SME), driving scientifically sound, phase-appropriate method strategies that meet GMP, ICH, USP, and regulatory expectations.
This role operates at the intersection of analytical science, regulatory compliance, and cross-functional program delivery - collaborating closely with QC, CMC Regulatory, manufacturing, and external CDMO partners to ensure analytical readiness for late-phase development milestones and regulatory submissions.
Key Responsibilities:
Analytical Method Development & Optimization
- Lead the design, development, and optimization of analytical methods for radiopharmaceutical API and drug products, including small molecules, peptides, and radiolabeled compounds.
- Develop and optimize chromatographic methods (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, mass spectrometry, UV/Vis, 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 for late clinical phase through commercial programs.
- Identify and implement analytical technology improvements and method modernization initiatives to support continuous improvement and commercial readiness.
- Troubleshoot complex analytical method performance issues and implement robust, validated solutions.
Analytical Method Validation & Transfer
- Author method validation protocols and reports in full compliance with ICH Q2(R2), USP <1225>, and applicable regulatory guidance for late-phase and commercial programs.
- Lead analytical method qualification and validation activities at internal sites and external CDMOs/partners.
- Perform or oversee technology transfer of validated methods to QC release and stability testing laboratories.
- Prepare and review method transfer protocols, comparability studies, and qualification/validation reports.
- Ensure validation data packages are complete, defensible, and ready for regulatory submission.
Regulatory & Documentation
- Author analytical sections of CMC regulatory submissions (INDs, CTAs, NDA/BLA, MAA), including method descriptions, validation summaries, and specification justifications.
- Develop and justify release and stability specifications for starting materials, intermediates, and drug products in collaboration with CMC Regulatory and QA.
- Prepare responses to regulatory agency inquiries related to 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, providing technical analytical expertise as required.
GMP Quality & Compliance
- Ensure all analytical activities are conducted in compliance with cGMP, cGLP, applicable FDA, EMA, Health Canada, ICH, USP, PDA, and Lilly quality standards.
- Review and approve experimental data from internal labs and external CDMOs/vendors; interpret results and document conclusions accurately.
- Lead or support investigations of out-of-specification (OOS) results, analytical deviations, and aberrant data using robust root cause analysis methodology.
Cross-Functional Collaboration & External Partnerships
- Serve as the analytical chemistry SME for late-phase RLT programs, providing technical direction to cross-functional CMC teams.
- Build and maintain productive working relationships with internal, external CDMOs, analytical service providers, and regulatory partners.
- Collaborate with QC, CMC Regulatory, Manufacturing Sciences, and Supply Chain to ensure seamless analytical readiness for clinical and commercial supply.
- Represent analytical capabilities in project team meetings, technical reviews, and governance forums.
Basic Requirements:
- Earned Bachelor's degree in chemistry, analytical chemistry, or organic chemistry
- 10+ years of relevant experience in analytical development, analytical validation, and/or analytical testing in a GMP setting.
- Demonstrated expertise in the development and full ICH Q2(R2)-compliant validation of chromatographic (HPLC, UPLC, GC, TLC) and spectroscopic (MS, UV/Vis, gamma) analytical methods.
- Functional knowledge of GMP regulations and applicable FDA, EMA, ICH, USP, and PDA guidelines relevant to analytical testing.
- Proven ability to operate effectively in a cross-functional environment with strong project management and organizational skills.
- Proficiency in analytical data systems and laboratory informatics (e.g., Empower, Chromeleon, MassLynx).
- Strong oral and written communication skills, with demonstrated ability to present technical data to diverse audiences including senior leadership and regulatory agencies.
- Must be a Canadian citizen to be selected for this position.
Additional Preferences:
- Master's degree in chemistry field with 5+ years of relevant experience, OR PhD in chemistry field with 2+ years of relevant experience
- Experience working hands-on within the biotech or pharmaceutical industry
- Experience with radiopharmaceutical analytical testing, including HPLC with radiometric detection, TLC (radiometric), 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 (ICH Q14, Q8/Q9/Q10 pharmaceutical quality system principles).
Other Information:
- Standard PPE and radiological safety protocols apply in RLT manufacturing and laboratory areas.
- Estimated travel: 5-15% domestically and internationally (CDMOs, partner sites, conferences). A valid passport and eligibility to travel within North America and Europe are required.
- Monday through Friday, standard business hours; periodic off-hours responsiveness may be required in support of GMP manufacturing or regulatory timelines.
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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