Senior Director, Analytical Development CMC

<div class="content-intro"><p><em>Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, </em><em>is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.</em></p> <p><em> </em><em>Headquartered in Boston, Massachusetts, Centessa was recognized as a <strong>Great Place to Work</strong>® in 2026.</em></p></div><p><strong>Description of Role</strong></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">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. </span><span data-ccp-props="{}"> </span></p> <p><strong>Key Responsibilities</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Lead analytical strategy related to phase-appropriate method development, validation, and product characterization for multiple programs</span></li> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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</li> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Review method validation protocol and reports, and test data for release, stability, and characterization</li> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol"