Senior Director, Analytical Development CMC

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.  Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Centessa’s  CMC group is seeking a Senior Director of Analytical Development within the CMC group. The successful candidate will have hands-on experience in the development and validation of raw material, in-process, small molecule drug substance, and solid oral dose drug product methods at all stages of development.    Reporting to the Executive Director , this role  will drive analytical method gap assessments, method development, and strategy at various CDMOs and liaise cross-functionally with drug substance and drug product teams across programs.  Comprehensive working knowledge of cGMP and Regulatory guidance as they relate to regulatory starting material, drug substance and drug product development, characterization, release, and stability testing of small molecules is paramount.      This position will be accountable for all analytical CMC data from external CDMOs to meet company deliverables and timelines.  Travel to vendors both domestically and internationally will be required .

Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs   Collaboratively work in a team environment to lead drug substance and drug product analytical development activities primarily at third-party vendors including method implementation, qualification/validation, and transfer in support of pre-IND through Registrational programs   Review method validation protocol and reports, and test data for release, stability, and characterization   Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments   Lead specification settings based upon batch history and supporting analytical data   Act as the CMC team analytical representative member in program development teams     Act as role model and subject matter expert for junior analytical scientists   Significantly contribute to CMC analytical aspects of regulatory filings including regulatory starting material justifications, justification of specifications, discriminatory and quality control dissolution method development, and structural elucidations   Review and drafting of internal technical reports and information for analytical sections in global submission documents and modules ( e.g. IND, IMPD, NDA, MAA, etc ) as well as responses to Regulatory requests for information   Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting   Active participation in batch record review    Minimum Qualifications: Advanced degree in chemistry,