Advisor Projects & Strategy Analytical GMP Laboratories Lilly Medicine Foundry
Scorpion Therapeutics, Lebanon, Indiana, United States, 46052
Role Summary
Advisor/Sr Advisor of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase-appropriate, risk-based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement. Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Some travel (0–10%) may be required. Responsibilities
Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing. Develop integrated method readiness strategies, including validation and transfer across multiple modalities. Oversee CMC analytical activities, specifications, stability strategies, and lifecycle elements. Support digitalization initiatives and implementation of new technologies to enhance analytical workflows. Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance. Champion continuous improvement initiatives and analytical lifecycle performance metrics. Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle. Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercial objectives. Act as a key liaison for technology transfer and method strategy across Foundry operations. Education
MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline. Qualifications
Required: 10+ years of experience in analytical development, GMP laboratories, or CMC functions. Required: Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks. Preferred: Proven cross-functional leadership experience. Preferred: Experience across synthetic and biological modalities. Preferred: Familiarity with PAT, automation, and high-throughput workflows. Preferred: Continuous improvement mindset with demonstrated CI experience. Preferred: Strong strategic thinking, influence, and stakeholder management skills. Additional Requirements
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2026 and 2027. Position requires on-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc. 0-10% travel required.
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Advisor/Sr Advisor of Project & Strategy for Analytical GMP Laboratories will lead clinical manufacturing and analytical strategy for GMP testing laboratories at the Lilly Medicine Foundry. This role drives phase-appropriate, risk-based analytical strategies from development through GMP execution, oversees strategic planning across CMC analytical deliverables, and partners cross-functionally to align analytical strategy with compliance, capability build, and digital enablement. Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Some travel (0–10%) may be required. Responsibilities
Define and lead phase-appropriate, risk-based analytical strategies to support clinical manufacturing. Develop integrated method readiness strategies, including validation and transfer across multiple modalities. Oversee CMC analytical activities, specifications, stability strategies, and lifecycle elements. Support digitalization initiatives and implementation of new technologies to enhance analytical workflows. Drive adoption of PAT, automation, and high-throughput approaches for efficiency and compliance. Champion continuous improvement initiatives and analytical lifecycle performance metrics. Ensure alignment with GMP, ICH guidance, and regulatory frameworks throughout the product lifecycle. Partner with QA, QC, Manufacturing, Engineering, and R&D to ensure analytical strategies support clinical and commercial objectives. Act as a key liaison for technology transfer and method strategy across Foundry operations. Education
MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline. Qualifications
Required: 10+ years of experience in analytical development, GMP laboratories, or CMC functions. Required: Strong understanding of ICH guidance, GMP principles, lifecycle management, and regulatory frameworks. Preferred: Proven cross-functional leadership experience. Preferred: Experience across synthetic and biological modalities. Preferred: Familiarity with PAT, automation, and high-throughput workflows. Preferred: Continuous improvement mindset with demonstrated CI experience. Preferred: Strong strategic thinking, influence, and stakeholder management skills. Additional Requirements
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the Lilly Medicine Foundry in Lebanon, Indiana. Flexibility to work from Indianapolis (or other Lilly sites) may be required throughout 2026 and 2027. Position requires on-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc. 0-10% travel required.
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