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About the Role
Neurona Therapeutics is developing transformative cell therapies for patients with serious neurological disorders. This role provides technical leadership and manufacturing support for GMP cell therapy operations, focusing on batch record review, investigations, troubleshooting, and continuous improvement.
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.
Requirements
- 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.
Skills
- Cell therapy
- Cell culture
- Bioreactor
- Advanced therapy manufacturing
- Technical writing
- Analytical skills
- Communication skills
- Problem-solving skills
Location
- South San Francisco, CA, 94080
Work Type
- Full Time
- On-Site
Experience Level
- 8+ years of relevant industry experience
Education Level
- Bachelor’s degree in Science, Engineering, Biotechnology, or related field
About the Company
- At Neurona Therapeutics, we are developing transformative cell therapies for patients with serious neurological disorders.