Job Details

Manufacturing Associate

Company Overview:
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of allogeneic cell-based therapies for neurological diseases.

Neurona's lead product candidate, NRTX-1001, comprising GABAergic interneurons, offers a novel approach that is not tissue-destructive for the potential treatment of drug-resistant focal epilepsy. NRTX-1001 is currently being studied for safety and efficacy in two ongoing open label multicenter, Phase 1/2 trials: NCT05135091 for drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), and NCT06422923 for drug-resistant bilateral MTLE. Neurona plans to initiate the Phase 3 EPIC (EPIlepsy Cell Therapy) trial in 2H 2025. The Phase 3 EPIC trial will be for patients with drug-resistant unilateral MTLE with mesial temporal sclerosis.

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 science, and take part in building an exciting, science-driven company.

Responsibilities:

• Participate and execute small-scale and at-scale process development experiments and develop viable cGMP manufacturing processes for cell culture and cryopreservation.
• Participate in the design, development, and implementation of processes to manufacture human neural cell therapeutics from pluripotent stem cells towards execution of the process on the manufacturing floor.
• Assist with maintaining laboratories (equipment maintenance, calibration, cleaning and related documentation).
• Participate in and execute cGMP manufacturing operations on the production floor.
• Ensure all safety and compliance procedures are always followed.
• Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
• Participate in and drive raw material and vendor qualifications
• Provide troubleshooting, technical support, and resolution of equipment, raw materials, and process issues on the manufacturing floor.
• Write and revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
• Lead resolution of Non-Conformances/Process Deviations and execution of Corrective and Preventive Actions (CAPA).
• Collaborate with Quality and other functional groups internally and at CMO to resolve manufacturing events in a timely manner.
• Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Collaborate with Quality, Manufacturing Managers, CMO staff and Regulatory Compliance staff in cross-functional teams.
• Present data at departmental meetings.
• Must possess the ability to work independently or as a team.

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
• 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.

Please visit our website at www.neuronatherapeutics.com.

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Alert
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