Director, Digital Systems Strategy & Operational Technology at ElevateBio
ElevateBio · Waltham, United States Of America · Onsite
- Senior
- Office in Waltham
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:
As Director of Digital Systems Strategy & Operational Technology, you will be responsible for defining and executing the strategic vision for digital manufacturing systems across ElevateBio's manufacturing network. This role combines enterprise-wide digital systems strategy with operational technology leadership to drive digital transformation across our manufacturing operations. You will oversee the development of cohesive manufacturing technology architecture while ensuring operational excellence across platforms including MES, LIMS, automation systems, and their integration with enterprise applications. As a key member of the IT leadership team and strategic partner to Manufacturing Operations, you will make critical decisions that balance innovation with practical implementation, leading a team of automation and digital systems professionals to deliver transformative solutions that enhance manufacturing efficiency, compliance, and scalability.
Here's What You'll Do:
- Develop and execute the strategic vision for manufacturing digital systems across the enterprise
- Serve as decision authority for manufacturing technology platforms, architecture standards, and integration approaches
- Lead selection and implementation of manufacturing systems (MES, LIMS, Automation) that optimize production while ensuring compliance
- Build and mentor a team of automation and digital systems professionals with versatile skills
- Identify system inefficiencies and implement innovative solutions across the manufacturing network
- Drive integration between manufacturing systems and enterprise platforms
- Establish digital manufacturing governance and lead cross-functional technology forums
- Create transformation roadmaps aligned with business objectives for efficiency, cost reduction, and quality
- Ensure manufacturing systems maintain regulatory compliance with 21 CFR Part 11 and EU GMP Annex 11
Requirements:
- Bachelor's Degree in Information Technology/Science, Engineering, or related fields. MS or MBA preferred
- 10+ years of experience in manufacturing IT/OT systems, with at least 5+ years in a leadership role
- Deep knowledge of manufacturing digital systems including MES, LIMS, SCADA, and automation platforms supporting GMP operations
- Demonstrated success implementing enterprise-level manufacturing digital strategies
- Proven ability to make critical technology decisions that align with business objectives
- Track record of successful digital transformation initiatives in regulated manufacturing environments
- Excellent communication skills with ability to influence senior leadership
- Strong understanding of regulatory requirements for computerized systems in GMP environments
- Experience with cell and gene therapy manufacturing operations preferred
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.
