Manufacturing Associate II

Manufacturing Associate II

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:

• 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 2-5 years of industrial experience or equivalent.

Preferred Qualifications:

• 2-5 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.