Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO), is revolutionizing cell therapy manufacturing with their Industry 4.0 approach. They are seeking a Consumable Qualification Engineer to join their team in South San Francisco. This role is crucial for ensuring the safety and compliance of consumables used in advanced medical and pharmaceutical applications.
The position involves leading testing and validation efforts in compliance with ISO 10993, USP Class VI, and other regulatory standards. You'll work closely with various teams including Systems Engineering, R&D, Mechanical Engineering, Quality, and Manufacturing. The role requires expertise in biocompatibility testing, extractables and leachables analysis, and sterilization validation.
Cellares offers a competitive compensation package ranging from $90,000 to $210,000 annually, along with comprehensive benefits including medical coverage, 401(k) matching, and stock options. The company has raised over $355 million in funding and operates a commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.
This is an excellent opportunity for experienced professionals who thrive in a fast-paced, mission-driven environment and want to contribute to advancing cell therapy manufacturing. The role offers the chance to work with cutting-edge technology while making a significant impact on the accessibility of life-saving cell therapies.