Manager, ManufacturingLocation: South San Francisco, CA, 94080
Job Type: Full Time
Work Type: On-Site
Position SummaryReporting 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.
