ElevateBio
Senior Validation Professional, Quality Control
ElevateBio, Waltham, Massachusetts, United States, 02254
Senior Validation Professional, Quality Control
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 Validation Professional of Quality Control is responsible for overseeing method validation and overall validation readiness within Quality Control at our BaseCamp facility in Waltham. In this role, the Sr. Validation Professional will be responsible for developing validation plans/protocols, executing/organizing validation activities, analyzing data, documenting results, and maintaining compliance with regulatory standards for our cell and gene therapy programs transitioning from early clinical phase. In addition, this position will work closely with the Analytical Development, QC management, QC testing, and QA teams, as well as customers to ensure that validation objectives are met.Here’s What You’ll Do:Define the validation strategy, plan, and protocol for applicable methods based on regulatory requirements and industry standards, as well as client requirements.Collaborate with Analytical Development to ensure validation is consistent with, and utilizes, initial development, qualification, and method performance data.Collaborate with QC testing functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.Analyze associated data and report validation results.Ensure test methods and associated SOPs are appropriate for validation in preparation for commercial manufacturing. Collaborate on and oversee change controls, as needed.Support inspections and facility audits.Hire, train, and mentor supporting staff, as needed.Requirements:B.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 8 years of experience in GMP QC laboratory setting, or M.S. in a similar discipline with a minimum of 6 years of experience.Expertise with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).Ability to communicate and work independently with scientific/technical personnel.Strong knowledge of GMPs, SOPs, and Quality system processes.Excellent organizational skills.Experience with method validations for commercial products.Experience in cell and gene therapy manufacturing environment is a plus.Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.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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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 Validation Professional of Quality Control is responsible for overseeing method validation and overall validation readiness within Quality Control at our BaseCamp facility in Waltham. In this role, the Sr. Validation Professional will be responsible for developing validation plans/protocols, executing/organizing validation activities, analyzing data, documenting results, and maintaining compliance with regulatory standards for our cell and gene therapy programs transitioning from early clinical phase. In addition, this position will work closely with the Analytical Development, QC management, QC testing, and QA teams, as well as customers to ensure that validation objectives are met.Here’s What You’ll Do:Define the validation strategy, plan, and protocol for applicable methods based on regulatory requirements and industry standards, as well as client requirements.Collaborate with Analytical Development to ensure validation is consistent with, and utilizes, initial development, qualification, and method performance data.Collaborate with QC testing functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.Analyze associated data and report validation results.Ensure test methods and associated SOPs are appropriate for validation in preparation for commercial manufacturing. Collaborate on and oversee change controls, as needed.Support inspections and facility audits.Hire, train, and mentor supporting staff, as needed.Requirements:B.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 8 years of experience in GMP QC laboratory setting, or M.S. in a similar discipline with a minimum of 6 years of experience.Expertise with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).Ability to communicate and work independently with scientific/technical personnel.Strong knowledge of GMPs, SOPs, and Quality system processes.Excellent organizational skills.Experience with method validations for commercial products.Experience in cell and gene therapy manufacturing environment is a plus.Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.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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