Process Engineer

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 method development and qualification that can thrive in a fast-paced dynamic environment. The successful candidate will work as a member of the Process Sciences department and will be responsible for projects requiring design and qualification of process equipment. In addition, the candidate will interface with Manufacturing, Process Science, Facilities, Validation, QA, and Contract Engineering/vendor firms to produce detailed designs for procurement, construction, installation, start-up, and validation of process systems including systems for shipping product to clinical sites. 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:

• 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. Level based on years of experience.
• 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
• Travel to clinical sites or vendor sites may be required

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.

This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

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