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Senior Manager, QA Sterility Assurance
2 months ago
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 a Contamination Control and Sterility Assurance Senior Manager primarily responsible for design, implementation, and oversight of procedures to ensure the integrity, sterility, and quality of manufacturing processes. This individual will lead development and maintenance of contamination control strategies/programs, oversight of design and execution of aseptic process simulations, and ensure compliance with cGMP regulatory standards. A successful candidate in this position would combine technical expertise, regulatory knowledge, and a dedication to ensuring product quality and patient safety.Here's What You'll Do:Lead management of the site contamination control strategy and program.Facilitate microbiological/sterility assurance risk assessments.Participate in root cause investigation for OOS and deviations for Sterility Assurance, Aseptic Processing, and Microbiological non-conformance events.Author, review, and approve Quality records (deviations, CAPAs, change controls). and documentation (policies, standard operating procedures, work instructions).Quality partner for aseptic process simulation design and execution for Cell and Gene Therapy programs.Cross-functional on-the-floor coaching/training on aseptic operations, cleaning and microbial testing.Interact with clients and regulatory agencies as an aseptic subject matter expert.Requirements:BA/BS degree with 7+ years of experience in pharmaceutical, biotechnology, or biologics operation.5+ years of work experience in Microbiology Testing, Contamination Control, Aseptic Operations, and/or Sterility AssuranceWorking knowledge of microbiological and sterility testing, aseptic process simulations, environmental monitoring, clean room management, cGMP regulations is required.Strong communication and project management skills.Ability to work well in a face paced environment.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.
