Process Engineer - Biotech & Life Sciences

About Us

Neurona Therapeutics is a clinical stage biotherapeutics company focused on revolutionizing the treatment landscape for chronic diseases of the nervous system. Our mission is rooted in pioneering developmental neurobiology research. We specialize in discovering and developing allogeneic regenerative cell therapies with the potential to repair dysregulated neural circuits. We are committed to delivering first in class, innovative cell therapy solutions to address significant unmet medical needs.

Key Responsibilities

• Design and implement best practices for high throughput product fill and cryopreservation.
• Contribute to design, development and implementation of kits to shipped to clinical site
• Suggest design modifications to address risks and design in quality and safety.
• Support in managing process-related projects from inception to completion.
• Provide ad hoc technical support to Manufacturing (ex. Troubleshooting GMP equipment, technical input for SOPs and Production Records).
• Develop and maintain comprehensive process documentation, including standard operating procedures (SOPs), process flow diagrams, and batch records
• Ensure implementation of good engineering practices on all design activities.
  
  

Required Qualifications

• Requires Bachelor's Degree in chemical engineering or appropriate engineering/science fields.
• At least two years experience relevant to biotechnology-related field and project management.
• Candidate must have a thorough knowledge of cell culture, cell separation and recovery, and filtration techniques.
• Title will change depending on education and industry experience
  
  

Preferred Qualifications

• Experience in Process Scale-up, support utilities, fill and finish, and bioprocess Instrumentation and Controls is a plus.
• Experience in device development is a plus.
• Excellent writing, verbal communication, presentation, and interpersonal skills.
• Experience working within a Quality Management System is an asset.
  
  

Please note that this job description is not exhaustive and may be subject to changes and additions in alignment with the evolving needs of the organization. The role may entail additional responsibilities beyond those specified herein, as delegated by management.