Cell Therapy Manufacturing Tech Operations Manager

Neurona Therapeutics

South San Francisco (CA)

On-site

USD 150,000 - 210,000

Full time

3 days ago

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Job summary

Neurona Therapeutics seeks a Manager, Manufacturing (Technical Operations) to lead batch record reviews, investigations, and continuous improvement for GMP cell therapy operations in South San Francisco. You will partner with Quality, Process Development, and Facilities to ensure compliant, efficient manufacturing and readiness for product development programs.

The role emphasizes technical leadership, cross-functional collaboration, and problem-solving to drive manufacturing reliability and

Qualifications

Bachelor’s degree in science/engineering/biotech with 8+ years of relevant 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.

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.