Manufacturing Associate at Neurona Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Sep, 26

Salary

0.0

Posted On

22 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Manufacturing, Cell Culture, Bioreactors, Aseptic Processing, Cleanroom Operations, Technical Writing, Equipment Validation, CAPA, SOP Development, Troubleshooting, Process Transfer, In-process Testing

Industry

Biotechnology Research

Description

MANUFACTURING ASSOCIATE Location: South San Francisco, CA, 94080 ABOUT NEURONA THERAPEUTICS 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. POSITION SUMMARY Our ideal candidate is a self-motivated individual who has a passion for manufacturing in a research and production setting. 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. REQUIRED QUALIFICATIONS * Bachelor’s degree in science or engineering with 2+ years of industrial experience or equivalent. PREFERRED QUALIFICATIONS * 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.

Responsibilities

Execute cGMP manufacturing operations and support process transfer and continuous improvement activities on the production floor. Maintain equipment, write controlled documents, and collaborate with cross-functional teams to ensure product supply.