Process Development Scientist

Neurona Therapeutics is an early stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for scientific research. 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 include:

• Develop, optimize, characterize, and scale-up a variety of processes (cell culture, harvest, fill, cryopreservation and thaw) for the manufacturing of neural cell-based therapeutics from human pluripotent stem cells.
• Help lead technology transfer, training, and process monitoring activities at clinical manufacturing sites.
• Contribute to the development of analytical assays and release specifications.
• Provide manufacturing support. Participate in troubleshooting exercises to diagnose and resolve production problems through data analysis and process/equipment characterizations.
• Present data at project, team, and company-wide meetings. Generate scientific reports and contribute to CMC sections of regulatory submissions.
• Some travel to CMO sites may be required.
• Must possess the ability to work independently or as a team.
• Must maintain notebooks and electronic files associated with each experiment and prepare final experimental reports.
• Manage product and material inventories as needed throughout studies.

Required Qualifications:

• Ph.D. in Biochemical Engineering, life sciences or related scientific field with 0-2 years of industrial experience.
• In depth experience in mammalian cell culture and/or culture and expansion of stem cells is a requirement.
• Experience in flow cytometry, and development of production processes using bioreactors is necessary.
• Pluripotent stem cell and neuroscience training would be desirable.
• Experience in cell cryopreservation is a plus.
• Excellent computer, organizational, written and verbal communication skills.
• Familiarity with cGMP requirements preferred.
• Must be able to work independently and in multi-disciplinary teams.
• Able to take initiative to improve work processes, develop innovative scientific methodologies and approaches to enhance process productivity.