Elevatebio jobs

Supervisor, Manufacturing Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility such as CAR-Ts, iPSCs, TILs, and mRNA. The individual should be a motivated self-starter eager to contribute to supporting a manufacturing organization unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. Here's What You'll Do: - Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, expansion, harvest, cryopreservation and final product visual inspection. - Lead manufacturing activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management. - Provide constructive input on teams for the selection and set-up of equipment, process and material flows, etc. - Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products. - Work effectively with cross functional teams comprised

Director, Supply Chain Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio BaseCamp is looking for a collaborative leader to drive meaningful changes and implement end-to-end supply chain strategies, operational plans, KPIs and objectives at the BaseCamp Waltham site. This role will partner closely with functional leadership to drive Planning, Master Production Scheduling, Forecasting, Inventory, Material Planning, and other supply chain capabilities for global clinical and commercialization plans in a multi-modality advanced therapy manufacturing site. The Supply Chain director will have direct responsibility for site incoming demand plans, supply plans, and operational assessments. role is a critical part of the Waltham Site Leadership Team and reports directly to the Site Head. Here's What You'll Do: - Provide operational leadership for BaseCamp Waltham's Planning, Materials Management, and GMP Warehousing functions, including: - Site production scheduling, forecasting, and planning processes (e.g. Shop Floor Control/Tiered Meeting structure etc.) - Site-level Sales and Operations Planning (SOP) processes including Demand Planning, Production Planning, and Operational Planning for all products and product stages, including partnering with external accounts for joint-S&OP. Executes capacity modeling for existing partners and new potential partner demand forecasting including direct labor, suite modeling, and batch run scenarios. Supports Long Range Planning for suite utilization. - Material planning for products from

Biomanufacturing Associate I (Contract) Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility such as CAR-Ts, iPSCs, TILs, and mRNA. The individual should be a motivated self-starter eager to contribute to supporting a manufacturing organization unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. Here's What You'll Do: - Perform routine right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection. - Perform manufacturing activities including but not limited to reviewing / authoring SOPs and batch records, as well as material ordering / management. - Provide constructive input for the selection and set-up of equipment, process, and material flows, etc. - Execute and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of

Associate I, QC Microbiology (Contract) Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: The Associate I, QC Microbiology is responsible for performing routine activities at our Waltham facility. This role will be responsible for ensuring daily functions and responsibilities of the QC Microbiology group within the laboratory and clean rooms are completed accurately and efficiently. Activities of this position include but are not limited to, laboratory assays, environmental monitoring activities, data entry, and review. Here's What You'll Do: - Perform routine environmental monitoring, utility monitoring, and safety testing of Cell Therapy drug products, ensuring that all work is carried out per cGMPs and applicable policies and procedures. - Perform standard QC Microbiological assays. - Bioburden, Endotoxin, Sterility, Growth Promotion, TOC/Conductivity, etc. - Peer-reviewing assay results. - Performing routine Data Entry/Review with LIMS systems. - Perform routine QC Microbiology Environmental Monitoring and Utility Monitoring testing in Grade A/B/C and D cleanrooms. - Perform routine Preventative Maintenance (PMs) for QCM Equipment. - Support Quality Events including: Laboratory Investigations, Deviations, CAPA's, Change Controls and associated Quality Actions. Requirements: - Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with 0-2 years of experience in a GMP Quality Control microbiology lab setting. - Ability to communicate and work collaboratively cross departmentally and

Biomanufacturing Associate II (Contract) Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a dynamic individual to join and, contribute to building the manufacturing operations team at our BaseCamp facility. The incumbent will ultimately perform routine cGMP manufacture of multiple cell and gene therapy types/products at our state-of-the-art BaseCamp facility such as CAR-Ts, iPSCs, Adeno-Associated Virus (AVV) and Lentivirus (LV). The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. Here's What You'll Do: - Perform and lead routine right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection. - Perform manufacturing/operations start-up activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management. - Provide training to team on set-up and use of equipment, process and material flows, as assigned. - Ensure clean rooms are maintained in an organized and ready state. - Provide constructive

Associate II, Materials Management (Contract) Pittsburgh, Pennsylvania, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a Materials Management Associate II reporting to the Materials Senior Manager, Materials Management to join our Warehouse team. You will assist with all facets of a warehouse operation including receiving, inventory management, creating material kits for use in manufacturing as well logistics and shipping. This is a 6-month contract position. Here's What You'll Do: - Use SAP system to perform Goods receipts, Goods issues, inventory movement and other transactions. - Access vendor websites to obtain Certificates of Analysis (COAs). - Perform Kitting of GMP orders from SAP generated pick list. - Perform inventory management including executing Cycle Counts. - Use manual labor and pallet jacks to move both GMP and non-GMP materials to and from storage locations and shipping docks. - Cross train with other team members to ensure proper back up coverage. - Maintain high level of communication with internal and external customers. - Coordinate shipments and perform pack outs of GMP and non-GMP materials. - Access various business systems and input data with a high level of accuracy (i.e. SAP, MS Office, etc.) - Provide loading dock coverage for receiving deliveries and handing off shipments. - Replenish materials on

Specialist I, People & Culture (Contract) Pittsburgh, Pennsylvania, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a Specialist I, People and Culture to help launch and support our new facility in Pittsburgh, PA. This is an exciting opportunity to join as an early team member and play a pivotal role in shaping the foundation for both our People & Culture programs and Office Administration at the site. In this role, you'll be a key contributor in driving and supporting our company culture initiatives, while ensuring smooth day-to-day office operations. As our Pittsburgh site grows, so will your impact-making this an ideal position for someone who thrives in a dynamic and evolving environment. Partnering closely with our broader People and Culture team based in Massachusetts, you'll serve as the key resource on-site leading local initiatives, coordinating internal events, and ensuring an exceptional employee experience. You'll collaborate across all teams and levels, helping to foster connection, communication, and a strong sense of community with the broader company. Here's What You'll Do: - Partner closely with the broader People & Culture team to drive alignment on various initiatives and projects throughout the year. Examples being: facilitation of company/team outings, site town hall meetings, support of annual open enrollment and

Director, Quality Systems & Compliance Waltham, Massachusetts, United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: The Director, Quality Systems and Compliance provides strategic direction and oversight of Quality Systems, Compliance, and Business System Ownership to ensure execution meets regulatory requirements, industry best practices, and modern digital, data-driven expectations. This role is accountable for evolving the Quality Management System (QMS) into a digitally enabled, scalable, and continuously improving ecosystem supporting clinical through commercial operations. The incumbent serves as a senior Digital System Owner leader, transforming Quality Systems into intelligent, data-driven platforms that enhance compliance, improve operational performance, and enable decision-making. This role is a critical influencer across the organization, driving adoption and effective use of Quality Systems and ensuring they deliver measurable business value. Success requires leadership beyond traditional system management-delivering value from systems by translating compliance requirements into efficient, practical, and scalable solutions that enable the business to operate effectively and transparently while maintaining a strong compliance posture. Here's What You'll Do: - Quality Systems Leadership - Lead and continuously improve Quality Systems, including Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, and Audit/Inspection Management - Own and drive the program for continuous inspection readiness, ensuring sustained audit preparedness through proactive monitoring, internal audits, and system effectiveness

Not seeing what you're looking for? Join Our Talent Community! United States ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. Our Team We are a group of explorers who share a passion for constant discovery and cutting-edge technologies. We are committed to strengthen and accelerate the development of life-transforming therapies. We welcome individuals who are dedicated, driven, and eager to make an impact in their field. Whether you're a seasoned leader or just starting your career journey, we offer a wide range of roles across various disciplines. From R&D, Manufacturing, General & Administrative and more, we are always looking to connect with exceptional people who are intrigued about the potential of joining our team. Our Values - Ingenuity with Intention - Collaboration Without Borders - No Pretense- Full Transparency - Courageously Curious - Respect Perspective Behind our successful team are the values we place front and center of everything we do. These five principles are our due north that support our vision, set our culture, and solidify what we stand for. As our team expands, we are seeking individuals who embody these principles. Sound like you? If so, we'd love to hear from you! Awards & Recognition: Join a team that has been recognized for excellence in innovation and culture. View some of our