Job Description
Job Description
Core Responsibilities
• Execute all aspects of clinical manufacturing, including cell expansion, cell culture, purification, solution preparation, and weigh/dispense.
• Serve as a subject matter expert (SME) across multiple manufacturing areas and support new product introductions (NPIs) in collaboration with Biological Development and Tech Transfer teams.
• Maintain GMP compliance, perform environmental monitoring, and ensure accurate documentation (Batch Production Records, SOPs, logbooks) in line with GDP standards.
• Troubleshoot and manage single-use technology (SUT) throughout the manufacturing process.
• Monitor and control processes using data trending and statistical process control.
• Perform quality control checks, prevent contamination, and accurately record cell growth and production metrics.
• Collaborate with Quality Assurance and Production teams to meet production targets.
We are a company committed to creating di...
Core Responsibilities
• Execute all aspects of clinical manufacturing, including cell expansion, cell culture, purification, solution preparation, and weigh/dispense.
• Serve as a subject matter expert (SME) across multiple manufacturing areas and support new product introductions (NPIs) in collaboration with Biological Development and Tech Transfer teams.
• Maintain GMP compliance, perform environmental monitoring, and ensure accurate documentation (Batch Production Records, SOPs, logbooks) in line with GDP standards.
• Troubleshoot and manage single-use technology (SUT) throughout the manufacturing process.
• Monitor and control processes using data trending and statistical process control.
• Perform quality control checks, prevent contamination, and accurately record cell growth and production metrics.
• Collaborate with Quality Assurance and Production teams to meet production targets.
We are a company committed to creating di...
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