Manager, Manufacturing

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

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position:Manager, Manufacturing

Location: South San Francisco, CA

Job Id:367

# of Openings:1

Manager, Manufacturing

Job Type: Full Time

Work Type: On-Site

About Neurona Therapeutics

At Neurona Therapeutics, we are developing transformative cell therapies for patients with serious neurological disorders. We are seeking a Manager, Manufacturing (Technical Operations) to provide technical leadership and manufacturing support for GMP cell therapy operations.

Position Summary

Reporting to the Director of Manufacturing, this position will be responsible for batch record review, manufacturing investigations, technical troubleshooting, and continuous improvement of manufacturing processes and systems. The Manager will help ensure manufacturing activities are executed in a compliant, consistent, and efficient manner while identifying opportunities to improve operational performance and manufacturing readiness.

This leader will partner closely with Manufacturing, Quality, Process Development, and Facilities and Engineering to resolve manufacturing issues, assess and mitigate risks, support GMP documentation and change controls, and drive initiatives that improve manufacturing reliability, compliance, and efficiency. The role will serve as a key technical resource for manufacturing operations and contribute to the development of scalable processes and systems as Neurona advances its cell therapy programs.

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.

Neurona Therapeutics
490 Forbes Blvd, Suite 600
South San Francisco, CA 94080
[e-mail]