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 Senior MES Engineer to join our dynamic team. Reporting to the Associate Director of Automation Information Systems, this role will be instrumental in managing and optimizing our Manufacturing Execution Systems (MES). The Senior MES Engineer will lead and guide less experienced engineers, supporting our role as a Contract Development and Manufacturing Organization (CDMO) managing multiple projects simultaneously.
Here’s What You’ll Do:
- Manage MES Teams: Oversee both full-time employees and consultants, ensuring effective support for multiple tech transfer projects, system implementation projects, and improvement initiatives.
- Lead and Mentor: Guide and mentor MES engineers, fostering a collaborative and growth-oriented environment.
- Set standards for record development.
- MES Management: Serve as the TSO (Technical System Owner) for Apprentice Tempo MES, ensuring smooth transition from Syncade MES to Apprentice MES.
- Tech Transfer Support: Assist clients in understanding MES requirements during tech transfer projects, including change management, master data build timelines, and setting expectations for client involvement.
- Project Planning: Develop project charters and plans to aid stakeholders in comprehending the scope and workload expectations for business users. Work with end users to develop system roadmaps that meet the needs of the organization.
- Support Business System Owner(s) in leading meetings to inform stakeholders, determine priorities, and develop/maintain the MES roadmap.
- System Upgrades: Explore Apprentice integrations, fine-tune the Electronic Batch Record (EBR) build and testing strategy, and implement an Apprentice system upgrade process.
- Platform Development: Start building a templated platform within Apprentice to facilitate easier management of MES records and streamline operations.
- Documentation: Create and update documentation associated with MES activities, including SOPs and training content in Veeva, knowledge articles, and standard change templates in ServiceNow, checklist templates in Kneat, and manage QMS activities such as deviation investigations, CAPA implementations, and change control implementations.
Requirements:
Required Qualifications:
- 5-10 years direct experience in Life Science GxP Manufacturing.
- Proven experience managing MES teams, including both full-time employees and consultants.
- Strong project management skills, with the ability to develop comprehensive project charters and plans.
- Experience leading system upgrades and integrations, particularly with Apprentice MES.
- Proficiency in creating and managing detailed documentation, including SOPs, training materials, and knowledge articles.
- Familiarity with ERP and ERP/MES Integrations for material tracking.
- Understanding that the MES team’s primary goal is to support Manufacturing Operations.
Nice-to-Haves:
- Experience with SAP/MES Integrations
- Experience with Veeva, ServiceNow, and Kneat.
- Previous involvement in setting up software governance structures.
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.
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come.
The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
