Manufacturing Associate

Organization: Neurona Therapeutics

Position: Manufacturing Associate

Location: San Francisco Bay Area

Manager: VP, Manufacturing and Process Science

Status: Full-time, Exempt

Position Summary

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

• 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 and own 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 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, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
• Own Non-Conformances/Process Deviations and 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.

Requirements

• Bachelor's degree in science or engineering with 2-5 year experience industrial experience.

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
• Mechanical aptitude with ability and expertise
• Independently collaborate with outside vendors
• Understanding of analytical methods for in-process testing requirements in the manufacturing area
• Possess excellent trouble shooting 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.

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