Key Responsibilities. 1、 Adhere to GMP requirements, biosafety related regulations, company management systems, and other regulations to ensure the timeliness, correctness, authenticity, integrity, and traceability of information and data during the receipt, storage, and distribution of materials and products, and ensure the consistency of accounts, materials, and inventory systems. 2、 Evaluate, pick, and replenish cleaning gowning materials dail...
1. Responsibilities. 1. Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements. 2. Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity. 3. Work with user department on daily maintenance and provide support on equipment / ...
Key Responsibilities. Facility design and renovation. Construction project management. Harmonization of facility engineering systems and maintenance and HSE procedures and practice. Office accommodation/Cleanroom manufacturing space/Warehousing. Ensure equipment life cycle maintenance, manufacturing facility cleaning activities planning timeliness, building maintenance, and enforcement of safety and security measures. Develop and implement compre...
Position Summary. Reporting to the Senior Director, Regulatory Affairs and Clinical Sciences, the Director (D), Regulatory Affairs drives the company’s regulatory strategies for BLA, IND, CTA, MAA, and NDS submissions in North America, Asia-Pacific (outside China), and EU. The Director, Regulatory Affairs is a key member of project teams and is responsible for strategic development and management of plans to bring to approval the cell therapy and...
IT Compliance Supervisor. TOGETHER, WE MAKE CANCER CURABLE. Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to ma...
Warehouse Supervisor. Key Responsibilities. Adhere to GMP requirements, biosafety related regulations, company management systems, and other regulations to ensure the timeliness, correctness, authenticity, integrity, and traceability of information and data during the receipt, storage, and distribution of materials and products, and ensure the consistency of accounts, materials, and inventory systems. Evaluate, pick, and replenish cleaning gownin...
Warehouse Supervisor. Key Responsibilities. Adhere to GMP requirements, biosafety related regulations, company management systems, and other regulations to ensure the timeliness, correctness, authenticity, integrity, and traceability of information and data during the receipt, storage, and distribution of materials and products, and ensure the consistency of accounts, materials, and inventory systems. Evaluate, pick, and replenish cleaning gownin...
Facilities Operations Specialist. TOGETHER, WE MAKE CANCER CURABLE. Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapi...
Engineering Manager. Position Summary. The Engineering Manager provides support for the ongoing growth of operations at the CARsgen Therapeutics Research Triangle Park (RPT), NC facilities. The Engineering Manager will oversee and coordinate the daily operations of engineering staff while ensuring that company objectives and goals are met. The position will focus on facility, cleanroom, process equipment and analytical equipment support and conti...
Document Control Coordinator. Job Summary. This position is responsible for leading, establishing and maintaining a configuration management system capable of meeting regulatory, quality and company requirements for documentation in a Cell Therapy products manufacturing environment. Activities will include, but are not limited to, word processing of documents, maintaining GxP records in the QA archive, processing records both manual and Electroni...
Manufacturing Support Supervisor. TOGETHER, WE MAKE CANCER CURABLE. Led by an experienced management team of professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities spanning from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to leverage our position a leading biopharmaceutical company developing globally revolutionary cell th...
