Analytical Molecule Steward - QC

Position Overview

The Analytical Molecule Steward is a senior technical leadership role responsible for building and standing up DS (Drug Substance) analytical capability at the Lilly Houston site in startup phase, including technical transfer, method implementation, and analytical control strategy definition for oligonucleotide and small molecule DS analytics.

• Lead DS analytical method technical transfer and startup at Houston; define technical transfer and knowledge-build strategies for oligonucleotide and small molecule modalities.
• Define and own analytical control strategy for assigned molecule(s) across manufacturing steps.
• Partner with TS/MS, Engineering, and site leadership on equipment/method/infrastructure requirements for site readiness and process validation timelines.
• Author and maintain global/registered content methods, method packages, regulatory submissions, and RTQ responses for assigned molecule(s).
• Own and/or review molecule-related documents (material specifications, product comparability study reports, analytical section of integrated control strategy).
• Own reference standard control strategy; partner with CRSO on re-evaluation, replenishment, and replacement testing.
• Serve as network-level analytical steward for assigned molecule(s); represent Houston in governance forums and ensure connectivity to global AQCO initiatives.
• Ensure analytical technical review of APRs, yBPRS, AMPRs, and QPPAs; identify capability gaps and champion investments.
• Provide technical mentorship to Site Analytical Steward and QC analysts; guide analytical investigations/deviations; represent analytical sciences on Houston leadership teams.
• Maintain partnerships with platform/technology stewards (e.g., PAT, Bioassay, Micro/Endo, Cleaning); lead relevant AQCO work streams.

• Knowledge of analytical control strategies/technologies across oligonucleotide and/or small molecule modalities.
• Expertise in analytical chemistry and advanced technologies (e.g., UPLC, GC, LC-MS, IP-RP-HPLC, CE/CGE, FTIR) and how analytics connect to manufacturing.
• Analytical investigations, forensics, and troubleshooting.
• Ability to operate in an ambiguous greenfield environment; strong communication/influencing skills; effective mentorship.

• Ph.D. or Master’s in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (preferred; significant experience may offset).
• 8+ years in analytical sciences within pharmaceutical manufacturing (method development, validation, lifecycle management for drug substances).
• Experience with technology transfer, equipment qualification, and method transfers across sites, including regulatory submissions/audits/compliance.

• Oligonucleotide analytics experience (IP-RP-HPLC, CE/CGE, LC-MS sequence/impurity characterization) strongly preferred.
• Commercialization experience preferred (development/technical transfer through commercial release).
• Startup/greenfield experience and proven cross-functional leadership for continuous improvement.

• Anticipated wage: $126,000–$204,600; eligible for company bonus.
• Comprehensive benefits (e.g., 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits).