Manufacturing Manager, Cell Therapy Operations

Neurona Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Neurona Therapeutics in South San Francisco seeks a Manager, Manufacturing (Technical Operations) to provide technical leadership for GMP cell therapy manufacturing. You will oversee batch record review, investigations, CAPA, and change controls, while driving continuous improvement and ensuring compliance with cGMP and FDA requirements.

The role partners with Quality, Process Development, and Facilities to resolve issues, implement scalable processes, and support manufacturing readiness for

Qualifications

• Bachelor’s degree in Science, Engineering, Biotechnology, or related field with 8+ years of industry experience.
• Experience in a cGMP-regulated biotech/pharma or cell therapy environment.
• Strong experience with batch record review, deviations, investigations, CAPA, change controls, and GMP documentation.
• Experience troubleshooting manufacturing processes, equipment, materials, or production issues.
• Demonstrated experience leading continuous improvement and problem-solving initiatives.
• Strong technical writing, analytical, communication, and problem-solving skills.
• Ability to lead cross-functional activities and influence decisions across multiple functions.
• Cell therapy, cell culture, bioreactor, or related advanced therapy manufacturing experience preferred.

Responsibilities

• Lead review of executed batch records for accuracy, completeness, and GMP compliance.
• Identify trends from batch records and deviations; lead corrective actions.
• Lead or support deviation and non-conformance investigations, root-cause analysis, and CAPA development.
• Manage manufacturing-related change controls and assess impacts to processes and equipment.
• Provide technical troubleshooting for manufacturing issues with equipment, materials, or processes.
• Serve as a manufacturing SME for cross-functional teams and drive improvements.
• Author and review GMP documents (SOPs, batch records, protocols, reports).
• Support equipment qualification, validation, and manufacturing readiness activities.
• Analyze manufacturing data to identify risks and opportunities for improvement.
• Partner with Quality to ensure investigations are documented and resolved; support audits.

Skills

Batch record review

Deviations investigations

CAPA

Change controls

GMP documentation

Cross-functional leadership

Technical writing

Problem solving

Leadership in manufacturing

Education

Bachelor’s degree in Science/Engineering/Biotechnology

Tools

CAPA software

Document control systems

Process validation tools

Job description

Neurona Therapeutics in South San Francisco seeks a Manager, Manufacturing (Technical Operations) to provide technical leadership for GMP cell therapy manufacturing. You will oversee batch record review, investigations, CAPA, and change controls, while driving continuous improvement and ensuring compliance with cGMP and FDA requirements.

The role partners with Quality, Process Development, and Facilities to resolve issues, implement scalable processes, and support manufacturing readiness for