Senior Quality Validation Specialist

We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares team.  

The Quality Validation team at our IDMO Bridgewater facility will be responsible for providing Quality Assurance oversight of environmental, equipment (analytical and production), facility & utility, site automation, process validation & engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

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.