Executive Director, CMC

SUMMARYCentessa continues to expand its CMC group and currently seeks an Executive Director of CMC, to lead our small molecule development programs across all CMC functions. This individual will be responsible for driving technical strategies, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development from early-to late-stage development and clinical studies. This high-impact leadership role requires a blend of scientific expertise, operational savvy, business acumen, technical efficiency, and strategic foresight. The ideal candidate brings deep experience in small molecule drug development, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment.The Executive Director, CMC will report directly to the SVP, CMC and will have ownership across the CMC function to include strategy, direct reports, team management, cross-functional leadership, and external manufacturing on our pipeline programs. Travel to vendors both domestically and internationally will be required.RESPONSIBILITIESStrategic LeadershipOversee the implementation of end-to-end CMC strategy across Centessa's development programsTranslate development goals into robust CMC plans, ensuring alignment across R&D/early stage, Clinical, Quality, and Regulatory functionsDevelop long-term development manufacturing strategies that consider Phase 1/Phase 2 forecasting, demand forecasting, investment planning, inventory control, and vendor relationshipsProactively identify and mitigate technical, production, and supply chain risksOperational OversightAct as the CMC team representative member in cross-functional developmental teamsOversee outsourced manufacturing activities, including CDMO contract negotiations and performance managementEnsure timely delivery of clinical supply and maintain timelines for Registration/Primary Stability, PPQ/Commercial, and Phase 1/Phase 2 drug substance and drug product batches.Manage the development of budgets and timelines for CMC operations and report regularly to leadershipDrive cross-functional meetings and milestone planning to support timely execution across drug substance and drug product for development programsInterface closely with key stakeholders in Quality, Regulatory, Supply Chain, Clinical, Legal, Finance, Project Management, and Non-Clinical teams in the development and execution of CMC plansAssist in developing documents and maintain compliance consistent with GLP and GMP standards for pre-clinical, early- and late-stage clinical development (pre-IND through Phase 3+)Develop and oversee SOPs, protocols/reports, and phase-appropriate specifications for pharmaceutical development and manufacturing activitiesOversee technical transfer activities of API and drug product for supply chain resilienceManufacturing and Technical ExecutionSupervise drug substance and drug product manufacturing and coordination of labeling, packaging, and distributionOversee sourcing, planning, and logistics for raw materials, APIs, excipients, and required specialized critical reagents or equipment to meet production requirementsManage analytical method development and validation for starting materials, in-process controls, and final release and stabilityParticipate in manufacturing site visits and pre-approval inspection readiness initiativesIdentify, select, and manage CDMOs for process optimization, non-GMP and GMP manufacture and supply of API and drug product in support of ongoing pre-clinical and clinical programs, including delivery of scalable and cost-effective manufacturing routes that meet business requirementsRegulatory AffairsCollaborate with Regulatory Affairs to support the preparation and submission of CMC sections (INDs, IMPDs, NDAs, etc)Address CMC-related and pertinent cross-functional questions from regulatory authorities and ensure submission and response timelines are metQUALIFICATIONSThorough understanding of cGMP requirements for pharmaceutical productsStrong organizational, interpersonal, leadership, and decision-making skillsAbility to work independently in a fast-paced dynamic environment with multiple projects and competing prioritiesDemonstrated ability to coordinate CDMO activities in the development and commercialization of pharmaceutical productsExcellent organizational skills, project management skills and detail-orientated leadership approachStrong experience with chemical and physical characterization of small moleculesKnowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissionsUnderstanding of product quality attributes control strategies as applied to small molecule synthetic processesEXPERIENCEMaster's degree in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline (PhD strongly preferred).Minimum 18 years of pharmaceutical industry experience including at least 8 years in CMC.Strong track record in CMC leadership across small molecule early-phase development and late-stage filing activities, including management of US and international CDMOsExtensive experience working with CDMOs and managing external partnershipsIn-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturingDemonstrated success in process development, scale-up, and validationPrior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets, and interacting with global health authorities (IND, IMPD, NDA, MAA)Strong communication, project management, and organizational skillsProven ability to lead cross-functional teams in a fast-paced, evolving environmentStrong skills in identifying and resolving critical issuesStrong track record in effectively working with senior managementCompensationThe annual base salary range for this job level is $300,000 – $340,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.In addition to base pay, this role is eligible for a discretionary annual bonus. 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.POSITIONFull-Time, ExemptEEOC StatementCentessa 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.Referral PolicyWe will not assign referral rights for any unsolicited resumes from recruitment agencies.J-18808-Ljbffr