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Senior Manager, QC Raw Materials

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Waltham, United States Vertex Ventures HC Full time

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: The Senior Manager, Quality Control will work cross-functionally with Technical Operations/ Manufacturing Sciences & Technology, Manufacturing, Supply Chain, Quality Control and Quality Assurance to implement and manage the Raw Material Program at our Waltham Base Camp facility. Specifically, this position will work to establish control strategies, specifications and testing & inspection procedures for raw materials used to manufacture clinical-stage gene and cell therapy products. Here’s What You’ll Do: Manage and develop the team responsible for the Quality Control Raw Materials program, the QC Raw Materials Testing Laboratory and outsourced raw material testing labs. Serve as the business system owner for the Quality Control Raw Materials program, including:

Raw Material risk assessments Raw Material specifications Inspection of Raw Materials Release of Raw Materials In-house testing of Raw Materials Outsourced testing of Raw Materials Raw Material retains

Develop and implement efficient, phase-appropriate, risk-based control strategies for raw materials using applicable GMP regulations and compendial monographs, with close interdependence to the Technology Transfer program and Supplier Quality program. Oversee and manage routine raw material testing and release in LIMS and ERP systems. Draft, review and approve raw material SOPs, test methods, specifications and associated protocols and reports. Manage lifecycle of Raw Material program elements and other projects related to materials, suppliers, and service providers, in collaboration with QA, QC, Technical Operations and Manufacturing teams. Collaborate on and oversee material/supplier-related Change Controls, CAPA, Deviations events, including Non-Conforming Material procedures and Supplier Corrective Action Requests. Assess Supplier Change Notifications and changes to compendial monographs. Support regulatory inspections, supplier audits, and client audits Lead, facilitate and participate in Quality meetings, Raw Material Review Board, Supplier Review Board and Quality Management Review. Promote a culture of Safety, Quality and GxP continuous improvement across the organization including training initiatives. Requirements: BS in a scientific discipline with 8 years’ experience in pharmaceutical / biotech industry within Quality Control or Quality Assurance, at least 4 years managing QC Testing Laboratory Experience with raw material testing programs and methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, and HPLC) Ability to communicate and work independently with scientific/technical personnel. Strong knowledge of GMPs, SOPs, and Quality system processes. Excellent organizational skills. Experience in cell and gene therapy manufacturing environment a plus Experience performing laboratory investigations, including out of specification investigations 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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