Senior Manager, CMC Operations and Program Management

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: ElevateBio is looking for an outstanding candidate to join our CMC Operations and Program Management department in support of our growing client portfolio for genomic medicines. This role is responsible for organizing process performance qualification (PPQ, process validation) and commercial readiness activities in support of advanced therapies. The Manager will lay the organizational foundation for the process validation program while integrating all essential deliverables from the cross-functional team. Candidates should have extensive experience with program management, biologics/CGT manufacturing in a commercial GMP setting, PPQ planning and execution, supporting regulatory filing and inspections, and working within highly matrixed cross-functional teams. Here’s What You’ll Do: Lead and manage commercial readiness and PPQ activities ensuring the team stays on track with promised deliverables. Run daily and weekly coordination meetings to ensure all activities that impact PPQ readiness are managed and resolved effectively. Develop a fully-integrated timeline for PPQ readiness inclusive of all cross-functional activities and actively manage to keep the program on time. Contribute to the overall framework for PPQ approach. Anticipate and manage risks to PPQ timeline, implementing mitigation strategies where possible. Collaborate with cross-functional teams, including external client teams as well as internal Quality, Regulatory Affairs, and Manufacturing, to ensure seamless execution of PPQ activities. Ensure the preparation and review of PPQ protocols, reports, and related documentation occur according to plan. Manage the timing of the design and execution of supporting BLA enabling studies such as filter validation, shipping validation, aseptic process validation, etc. Establish and support life cycle management program for post-approval changes. Ensure successful delivery of commercial batches in partnership with MSAT, Manufacturing, Supply Chain, Quality, and supporting functions by providing oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition. Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs, etc.). Actively support PAI readiness and regulatory inspections of BaseCamp Waltham site. Requirements: B.S. in a scientific or engineering discipline. At least 5 years of experience in CMC program management. Experience in autologous gene or cell therapy preferred. PPQ oversight and program leadership for process validation is required. Demonstrated ability and strength in leading cross-functional technical teams within a matrixed organization. A strong technical leader who can problem-solve while balancing business needs with technical risks within a regulated environment. Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH guidelines). Prior experience with regulatory submission and regulatory inspection is strongly preferred. Excellent project management, organizational, and communication skills including communication with senior leadership and external stakeholders. Outstanding planning, organization, and multitasking skills. Experience working within a contract manufacturing or client service organization strongly preferred. On-site presence required – routine interface with commercial readiness team on-site (role may be hybrid). Why Join ElevateBio? ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics. We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease. Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves. Our Vision: We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated. ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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