[Remote] Director, CMC Program Management - Drug Substance

Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals is a new kind of pharmaceutical company focusing on a deconstructed R&D environment that prioritizes data-driven decision making. They are seeking a Director of CMC Program Management for Drug Substance to lead the development and manufacturing of small molecule programs, ensuring effective execution of CMC deliverables in coordination with program and corporate goals.ResponsibilitiesPartner closely with the CMC project lead to devise project strategic goals and drive these through seamless tactical executionServe as a point of contact for all CMC project-related communications especially focused on drug product development, manufacturing, release, packaging, labeling, and stability coordinationFoster strong relationships with internal teams, and external partners including CDMOsParticipate in regular telecon meetings with CDMOs to maintain the business relationship, progress, meeting notes and action itemsMonitor timelines and contracts for accuracy and follow up on any discrepancies with contractors and/or internal personnelSupport CMC activities including tracking relevant GMP and Regulatory documentationInterfaces with drug substance, drug product, analytical, non-clinical, clinical, Regulatory, supply chain, and Quality colleagues to ensure all projects are delivered on time, within scope and budgetWork with CMC team members to identify resource constraints, risks, and conflicts that could impact the team’s bandwidth and/or company timelinesCover all other project management requirements including shipment/logistics coordination, inventory, and production planningIn collaborations with the CMC lead, drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across functions with timelines, work plans including interdependencies, gating items, budget, and risk management strategiesOversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraintsFacilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and prioritiesCommunicate project updates consistently to various stakeholders, about strategy, adjustments, and development progressExperience utilizing project management tools and best practices to support CMC activitiesExcellent attention to detail, communication, time management, organizational skills, and flexible attitude to work assignments and new learning with proven ability to interact in a team environmentComfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing informationProject management professional (PMP) certification preferredExpert MS Office skills including Excel, PowerPoint, MS Project, and other PM timeline software (e.g. Smartsheet)SkillsBS/MS in a scientific discipline; PhD preferred10+ years of relevant pharmaceutical industry experience, including 7+ years leading CMC project/program management activitiesProven experience in small molecule drug development, with emphasis on drug substance/API requiredProficient understanding of the end-to-end drug development process, including CMC, non-clinical, clinical, and regulatory activitiesDemonstrated knowledge of CMC requirements across all phases of clinical developmentThorough understanding of cGMP regulations for pharmaceutical productsExperience coordinating and managing CDMO activities supporting development and commercializationStrong project management, organizational, and prioritization skills to manage multiple, evolving programsExcellent decision-making, analytical, and resource management skills in dynamic, global environmentsEffective communicator with the ability to clearly convey complex scientific information both verbally and in writingAbility to work independently while collaborating cross-functionally and with stakeholders at all organizational levelsSelf-motivated, results-driven, adaptable to changing priorities, and willing to travel domestically and internationallyProject management professional (PMP) certification preferredExpert MS Office skills including Excel, PowerPoint, MS Project, and other PM timeline software (e.g. Smartsheet)BenefitsDiscretionary annual bonus401(k) planCompany-sponsored medical, dental, vision, and life insuranceGenerous paid time offHealth and wellness programCompany OverviewCentessa Pharmaceuticals is a pharmaceutical company that focuses on drug development to address significant medical needs. It was founded in 2021, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 51-200 employees. Its website is https://www.centessa.com.Company H1B SponsorshipCentessa Pharmaceuticals has a track record of offering H1B sponsorships, with 1 in 2025, 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.