Cell and Gene Therapy Operations Manager

1 week ago

Waltham, Massachusetts, United States ElevateBio Full time
Job Summary:

ElevateBio is a technology-driven cell and gene therapy company accelerating access to 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 Associate Manager, CMC Operations and Program Management will lead cross-functional activities between CMC groups and other departments at ElevateBio BaseCamp, including process development, analytical development, facilities, and engineering, and supply chain within the scope of various programs. The Associate Manager will be part of the BaseCamp CMC and Program Management department and will aid in supporting both internal portfolios at BaseCamp. This position will contribute to ensuring alignment with corporate goals and timelines.

Key Responsibilities:
  • Be an integral part of ElevateBio's BaseCamp operations by leading cross-functional teams that are coordinating and maintaining program timelines.
  • Run daily and weekly coordination meetings to ensure all activities that impact CMC operations are managed and resolved effectively.
  • Maintain integrated program plans and actively manage to keep programs on time.
  • Anticipate and manage risks to portfolio and individual programs, implementing mitigation strategies.
  • Contribute to the management and review of KPIs at BaseCamp.

Requirements:
  • B.S. in a scientific or engineering discipline.
  • 3 or more years of relevant experience in the CMC environment. Cell/gene therapy preferred.
  • cGMP program management experience is required.
  • Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products is preferred.
  • Extensive experience leading product/process program within a GMP setting.
  • Program management skills, including strategic and tactical programs/tasks, tracking and adhering to budgets, reporting program and campaign metrics, and other program management tools.
  • Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills.
  • Outstanding planning, organization, and multitasking skills.

About 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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