Senior Director, Analytical Development, CMC Small Molecule

<div class="content-intro"><p>Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.</p> <p>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.</p> <p> </p></div><p><strong>Description of Role</strong></p> <p><span data-contrast="none"><span data-ccp-charstyle="Strong">Centessa</span><span data-ccp-charstyle="Strong">’s</span><span data-ccp-charstyle="Strong"> CMC group </span><span data-ccp-charstyle="Strong">is seeking </span><span data-ccp-charstyle="Strong">a</span><span data-ccp-charstyle="Strong"> Senior Director of Analytical</span><span data-ccp-charstyle="Strong"> Development</span><span data-ccp-charstyle="Strong"> 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-charstyle="Strong">T</span></span><span data-ccp-props="{"335557856":16777215,"335559739":240}"> </span></p> <p><span data-contrast="none"><span data-ccp-charstyle="Strong">Reporting to the VP, CMC, the</span><span data-ccp-charstyle="Strong"> Senior Director</span><span data-ccp-charstyle="Strong"> 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><span data-ccp-props="{"335557856":16777215,"335559739":240}"> </span></p> <p><span data-contrast="none"><span data-ccp-charstyle="Strong">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><span data-ccp-props="{"335557856":16777215,"335559739":240}"> </span></p> <p><strong>Key Responsibilities</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">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="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" 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="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" 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="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Save and store documentation, generate stability result tables, file stability data for expiry and shelf-life assignments</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Lead specification settings based upon batch history and supporting analytical data</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Act as the CMC team analytical representative member in program development teams <span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[1440],"469777927":[0],"469777928":[8]}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Act as role model and subject matter expert for junior analytical scientists</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Work cross-functionally with Quality as a technical expert to aid in analytical OOE/OOT/OOS investigations, deviations, and other troubleshooting</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Active participation in batch record review<span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[1440],"469777927":[0],"469777928":[8]}"> </span></li> </ul> <p><strong>Qualifications</strong></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Advanced degree in chemistry, pharmaceutical sciences, or related field (minimum BS/MS required; PhD strongly preferred) with 15+ years of small molecule pharmaceutical industry experience</span></li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Extensive experience in late phase analytical development of small molecule oral solid dosage forms</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Deep expertise in cGMP and ex-US regulatory requirements for pharmaceutical products</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Strong technical background in chemical and physical characterization, including polymorphism, particle size, residual solvents, process impurities (e.g., genotoxic, nitrosamines), and forced degradation mechanisms</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Significant experience in analytical method development and GMP qualification/validation, including assay, related substances, and dissolution</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Proven ability to manage and direct outsourced analytical activities, including assay development, stability, and quality control at CDMOs</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Hands-on experience designing, managing, and interpreting stability programs (real-time, accelerated, and forced degradation)</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Strong understanding of product quality attributes and control strategies for small molecule synthetic processes</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Demonstrated leadership in coordinating analytical and broader CMC activities supporting development and commercialization</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Excellent project management, organizational, and prioritization skills in fast-paced, multi-project environments</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Strong analytical planning, resource management, and budget oversight skills across global CDMO networks</li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Effective decision-maker and communicator, able to work independently while collaborating across functions and organizational levels<span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240,"469777462":[1440],"469777927":[0],"469777928":[8]}"> </span></li> </ul> <p><strong><span data-contrast="auto">Compensation</span></strong><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">The annual base salary range for this position is $240,000.00 to $290,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa’s long-term success.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.</span><span data-ccp-props="{}"> </span></p> <p><strong>Work Location</strong></p> <p><span class="TextRun SCXW170338807 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW170338807 BCX0">The </span><span class="NormalTextRun SCXW170338807 BCX0">Senior Director, Analytical Development, CMC </span><span class="NormalTextRun SCXW170338807 BCX0">(</span><span class="NormalTextRun SCXW170338807 BCX0">Small Molecule</span><span class="NormalTextRun SCXW170338807 BCX0">)</span><span class="NormalTextRun SCXW170338807 BCX0"> </span><span class="NormalTextRun SCXW170338807 BCX0">role is a remote role based in the US, with travel</span><span class="NormalTextRun SCXW170338807 BCX0">.</span></span><span class="EOP SCXW170338807 BCX0" data-ccp-props="{"201341983":0,"335559739":120,"335559740":240}"> </span></p> <p><strong>POSITION:</strong> Full-Time, Exempt</p> <p> </p><div class="content-conclusion"><p>EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.</p> <p><strong><span class="break-words tvm-parent-container">Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.</span></strong></p></div>