Production Specialist II Cell Therapy Cell Culture - Berkeley, CA

Role: Production Specialist II in Cell Therapy manufacturing, focusing on clinical-grade cell therapy drug substance production within the CT-MOD platform. Responsibilities include operating and executing aseptic manufacturing processes such as solution prep, cell expansion, culture, and final fill, supporting new product introductions, process monitoring via data trending, troubleshooting equipment, authoring and reviewing controlled documentation, and supporting commissioning and qualification activities. The role involves delivering training, ensuring safety, and driving continuous improvement initiatives. Qualifications: Bachelor’s in a science-related field with 2+ years of biotech/pharmaceutical manufacturing experience or an advanced degree; practical knowledge of aseptic techniques, cleanroom operations, cGMP compliance, data integrity, and regulatory standards (FDA, EMA). Skills include troubleshooting, proficiency with IT tools, and effective communication; physical capability to lift 45 lb. Flexibility for shift work and off-hour coverage is required. Preferred: Experience in cell therapy manufacturing, single-use technologies, pluripotent stem cell processes, and lean manufacturing. High-Value: biologics/cell therapy, clinical manufacturing, GMP environment, process validation, and cross-functional collaboration. Work setup: on-site in Berkeley, CA, with flexible shift support.