Manager, Manufacturing

Location

• South San Francisco, CA, 94080
• Job Type: Full Time
• Work Type: On-Site

About Neurona Therapeutics

Key Responsibilities

• Lead the review of executed batch records and manufacturing documentation for accuracy, completeness, and GMP compliance.
• Identify trends and recurring issues from batch records, deviations, and manufacturing data, and lead actions to address them.
• Lead or support deviation and non-conformance investigations, including root-cause analysis, impact assessment, and CAPA development.
• Manage manufacturing-related change controls and assess impacts to processes, equipment, materials, and documentation.
• Provide technical troubleshooting for manufacturing issues related to equipment, materials, processes, and production activities.
• Provide technical leadership and serve as a manufacturing subject matter expert for cross-functional teams.
• Lead continuous improvement initiatives to improve manufacturing reliability, compliance, efficiency, and consistency.
• Author and review GMP documents, including SOPs, batch records, procedures, protocols, and reports.
• Support equipment qualification, validation, manufacturing readiness, and process implementation activities.
• Analyze manufacturing data and trends to identify risks and opportunities for improvement.
• Partner with Quality to ensure manufacturing issues are appropriately investigated, documented, and resolved.
• Support audit and inspection readiness and ensure manufacturing activities comply with applicable cGMP and FDA requirements.
• Identify and communicate risks that may impact product quality, safety, supply, or manufacturing timelines.

Qualifications

• Bachelor’s degree in Science, Engineering, Biotechnology, or related field with 8+ years of relevant industry experience, or equivalent experience.
• Experience in a cGMP-regulated biotechnology, pharmaceutical, biologics, 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 Manufacturing, Quality, Facilities and Engineering, and other functions.
• Cell therapy, cell culture, bioreactor, or other advanced therapy manufacturing experience preferred.