Description
CELLARES | SOUTH SAN FRANCISCO,CA OR BRIDGEWATER, NJFULL-TIME
We are seeking an innovative and highly motivated Principal Enterprise Architect, GMP Systems who will play a critical role in the launch and ramp-up of a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
This role will be responsible for driving forward select initiatives within the Cellares IT department, particularly in developing and executing portions of the IDMO IT strategy. This role individual will be responsible for directing and coordinating the development of our IDMO IT infrastructure, including the planning, design, implementation, and documentation.
This is a multidisciplinary role, and the individual will need to be able to interface with all levels of the organization, including Operations, MS&T, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance.
The successful candidate should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Oversee the global IT function for GMP systems, ensuring consistency, scalability, and compliance across all regions
- Develop and maintain a comprehensive technical blueprint for GMP systems, aligning technology services with business objectives and regulatory requirements
- Provide architectural leadership in resolving inter-program and inter-project issues related to GMP systems
- Oversee the hiring, development, and performance management of staff within IT GMP Systems
- Partner with the IDMO Business to develop and execute against an IT roadmap and deliver on the IT infrastructure needed to manufacture autologous and allogeneic cell therapy products
- Drive the selection, implementation, and support of various business applications, including ERP, MES, LIMS, QMS, etc.
- Work closely with Validation and Quality in deploying and supporting IT GMP Systems
- Manage and coordinate employees, contractors, and agencies, contractors involved in development projects to ensure alignment with project goals, timelines, budgets, and quality standards
- Establish KPIs, monitor progress, and keep critical stakeholders informed of progress for IT projects and strategic initiatives
- Establish key stakeholder relationships with internal and external stakeholders
- Work closely with other functional areas to develop and execute against the strategic plan for all Cellares sites
- Develop, manage, and track a budget for the department
- Negotiates and contracts with consultants, technical personnel, and vendors for services and products needed to support the IDMO IT infrastructure
- Serve as a subject matter expert (SME) during audits or inspections by regulatory authorities.
Requirements
- Bachelor’s degree in computer science or related technical field
- A minimum of 10+ years within IT in a cGMP environment in the biotech/biopharma industry with a minimum of 5 years leadership experience. Cell/Gene Therapy and CDMO experience a plus
- Experience Implementing Manufacturing, Quality, and Supply Chain applications, including ERP, MES, LIMS, QMS, etc.
- Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment while providing clear direction to team member
- History of developing and building cohesive, high-performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
- Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
- Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization
- Excellent organizational and communication skills
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Other Jobs from Cellares
Senior Process Engineer
San Francisco, CA
Senior Software Engineer (I, II, III)
San Francisco, CA
Senior Mechanical Engineer (I, II, III)
San Francisco, CA
Principal Mechanical Engineer - Consumables
San Francisco, CA
There are more than 50,000 engineering jobs:
Subscribe to membership and unlock all jobs
Engineering Jobs
60,000+ jobs from 4,500+ well-funded companies
Updated Daily
New jobs are added every day as companies post them
Refined Search
Use filters like skill, location, etc to narrow results
Become a member
🥳🥳🥳 452 happy customers and counting...
Overall, over 80% of customers chose to renew their subscriptions after the initial sign-up.
To try it out
For active job seekers
For those who are passive looking
Cancel anytime
Frequently Asked Questions
- We prioritize job seekers as our customers, unlike bigger job sites, by charging a small fee to provide them with curated access to the best companies and up-to-date jobs. This focus allows us to deliver a more personalized and effective job search experience.
- We've got about 70,000 jobs from 5,000 vetted companies. No fake or sleazy jobs here!
- We aggregate jobs from 5,000+ companies' career pages, so you can be sure that you're getting the most up-to-date and relevant jobs.
- We're the only job board *for* software engineers, *by* software engineers… in case you needed a reminder! We add thousands of new jobs daily and offer powerful search filters just for you. 🛠️
- Every single hour! We add 2,000-3,000 new jobs daily, so you'll always have fresh opportunities. 🚀
- Typically, job searches take 3-6 months. EchoJobs helps you spend more time applying and less time hunting. 🎯
- Check daily! We're always updating with new jobs. Set up job alerts for even quicker access. đź“…
What Fellow Engineers Say
