Director, Manufacturing

Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for the manufacturing sciences and can thrive in a fast-paced dynamic environment. The successful candidate will work as a member of the Process Sciences department and be responsible for leading the efforts for CGMP manufacturing and supply chain of our cell therapy drug products. 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

• Lead production team for cell therapy Current Good Manufacturing Practices manufacturing (cGMP) and cGMP supply chain.
• Ensure timely onboarding of personnel to maximize training opportunities and to deliver all process and/or facility validation requirements.
• Work with site teams to integrate with and influence established site systems as needed to implement cell therapy production operations.
• Lead all manufacturing aspects including, but not limited to, generation of product specific documentation, supporting the introduction of new equipment, raw materials and/or consumables, determine safety implications if any and training of personnel.
• Lead qualification of processes as needed for production and to ensure readiness for production.
• Provide troubleshooting, technical support, and resolution of equipment, raw materials, and process issues on the manufacturing floor.
• Participate in and provide leadership in executing cGMP manufacturing operations on the production floor.
• Continuously seek opportunities for improving overall compliance and reduce discrepancies.
• Partner with Quality to implement and manage phase appropriate systems/processes/procedures to meet cGMP manufacturing requirements against regulatory standards in various regions (US/EU/etc.)
• Track adverse trends and ensure they are addressed quickly and effectively.
• Provide direction and/or act as escalation point for unresolved deviations/non conformances.
• Partner with Quality and Engineering representatives to implement effective corrective and preventative actions (CAPAs) to mitigate recurrence.
• Lead design, implementation and commissioning of manufacturing facilties.
  
  

Required Qualifications

• Manufacturing experience in biologics operations required, with cell therapy experience much preferred.
• Prior experience with all aspects of cell therapy manufacturing: aseptic processing, expansion and differentiation of allogenic and/or autologous cell therapy products, generation of cells in 3D and adherent cultures, and formulation/fill of cellular therapeutics.
• Proven ability to troubleshoot and resolve issues.
• Ability to monitor and control processes using data trending and/or statistical process control
• Strong leadership skills, ability to communicate and partner well with all levels of staff, to lead and motivate with emphasis on compliance and continuous improvement and to resolve conflicts.
• Excellent writing, verbal communication, presentation, and interpersonal skills.
  
  

Education Requirements

• Bachelor of Science and at least 15-20 years of industrial experience.
  
  

For immediate consideration, please email your resume to: jobs@neuronatx.com. Interested in learning more about our science and our team? 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.