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About the Role

This is a fantastic opportunity to join a small team, work on transformative cell therapies, and take part in building an exciting, science-driven company.

Responsibilities

• Execute cGMP manufacturing operations on the production floor.
• Support process transfer, implementation, and continuous improvement activities.
• Maintain laboratories and manufacturing areas, including equipment maintenance, calibration, cleaning, and documentation.
• Follow all safety, quality, and compliance requirements.
• Support equipment commissioning, qualification, validation, and ongoing lifecycle activities.
• Support raw material and vendor qualification activities.
• Troubleshoot equipment, materials, and manufacturing process issues.
• Write and revise controlled documents, including SOPs, manufacturing procedures, forms, and technical reports.
• Support investigations, deviations, non-conformances, and CAPA activities.
• Collaborate with Quality, Manufacturing, Regulatory, and CMO partners to support manufacturing operations and product supply.
• Escalate issues that may impact safety, quality, equipment performance, or product supply.
• Present manufacturing data and operational updates at departmental meetings.
• Work effectively both independently and within cross-functional teams.

Requirements

• Bachelor’s degree in science or engineering with 2+ years of industrial experience or equivalent.
• 2+ years of industrial experience in cGMP operations.
• Knowledge of cell culture operations and bioreactors.
• Knowledge of analytical equipment and computers.
• Knowledge of CFRs and cGMP requirements and ability to interpret and apply the knowledge.
• Aseptic processing, cleanroom operations, and cell culture experience a plus.
• Ability to independently collaborate with outside vendors.
• Understanding of analytical methods for in-process testing requirements in the manufacturing area.
• Possess excellent troubleshooting skills, technical writing capability, presentation and interpersonal skills.
• Able to take initiative to improve work processes, develop innovative scientific methodologies and approaches to enhance process productivity.

Skills

• cGMP manufacturing
• Process transfer
• Process implementation
• Process improvement
• Equipment maintenance
• Equipment calibration
• Equipment cleaning
• Documentation
• Safety compliance
• Quality compliance
• Compliance requirements
• Equipment commissioning
• Equipment qualification
• Equipment validation
• Raw material qualification
• Vendor qualification
• Troubleshooting
• Technical writing
• SOP writing
• Manufacturing procedure writing
• Investigation support
• Deviation support
• Non-conformance support
• CAPA support
• Collaboration
• Cross-functional team collaboration
• Presentation skills
• Interpersonal skills
• Cell culture operations
• Bioreactors
• Analytical equipment
• Computer proficiency
• CFR interpretation
• cGMP interpretation
• Aseptic processing
• Cleanroom operations
• Independent collaboration
• Analytical methods
• In-process testing
• Process improvement initiative
• Scientific methodology development
• Process productivity enhancement

Location

• South San Francisco, CA, 94080

Work Type

• Onsite

Experience Level

• 2+ years of industrial experience
• 2+ years of industrial experience in cGMP operations

Education Level

• Bachelor’s degree in science or engineering

About the Company

• Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of allogeneic, regenerative neural cell therapies for neurological disorders.
• Neurona's lead product candidate, rezanecel (formerly NRTX-1001), is an investigational cell therapy comprising GABAergic interneurons designed to provide a novel, non-tissue-destructive treatment approach for drug-resistant mesial temporal lobe epilepsy (MTLE).
• Rezanecel is currently being evaluated in ongoing multicenter Phase 1/2 clinical trials for patients with drug-resistant unilateral and bilateral MTLE and has demonstrated encouraging safety and efficacy results to date.
• The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to rezanecel in 2024, and the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation in 2025.
• Neurona is preparing to initiate its Phase 3 EPIlepsy Cell Therapy (EPIC) trial, a randomized, sham-controlled, double-blind study designed to further evaluate rezanecel in adults with drug-resistant MTLE.
• Through its pioneering cell therapy platform, Neurona is advancing innovative treatments intended to restore neural circuit function and address serious neurological disorders with significant unmet medical need.