Cell Therapy Specialist Ii - Cms
CurrentIn my role as a Cell Therapy Specialist II within the Manufacturing department at Dendreon, I play a pivotal role in launching the Contract Manufacturing Services (New Product Introduction) , assuming leadership responsibilities for various initiatives. As a representative for the Manufacturing department in cross-functional team meetings, projects, and GXP-related discussions, I contribute to process planning and improvements. Working closely with other Cell Therapy Specialists, I ensure compliance with cGMP standards during aseptic processing of clinical and commercial products, media simulations, and validation processes, while strictly adhering to SOPs and electronic batch records (eBR) to maintain product quality. Additionally, I actively participate in inventory management to optimize production outcomes and conduct thorough checks on raw materials to ensure their accuracy. I also contribute to the development and enhancement of SOPs, Master Batch Records, and training materials. Furthermore, I provide support for investigations, deviations, Corrective and Preventive Actions (CAPAs), and Change Controls related to raw material sampling, inspection, testing, and release processes as necessary. And support in tech transfer between Research development and manufacturing. Moreover, I facilitate the onboarding process for new team members through comprehensive training programs covering equipment operation, aseptic processing techniques, and hands-on instruction.