Manufacturing Associate III/II

Role Summary

Manufacturing Associate III/II to join our Manufacturing team to execute the manufacturing of iPSC-derived allogenic cell therapy products in a cGMP compliant clean room environment. Responsible for executing batch records, following SOPs, and performing manufacturing logistical support per cGMP, GDP and safety standards. Develop and apply skills across production activities including aseptic techniques, equipment operation, product sampling and enumeration, reagent and material preparation and cell processing. Full-time, non-exempt, located in San Diego, CA.

Responsibilities

• Execute cell culture manufacturing activities of iPSC-based drug product from thaw of MCBs through harvested cryopreservation and quarantine of drug product following approved batch records and SOPs.
• Work in a cleanroom environment, performing aseptic processing while maintaining manufacturing environmental conditions.
• Accurate and timely documentation of manufacturing activities performed.
• Document deviations and report deviations to department management.
• Maintain manufacturing facility in a clean and organized state.
• Maintain cGMP training requirements.
• Engage with supply chain and materials management to ensure adequate inventory of raw materials to support planned production activities.
• Work independently and collaboratively on manufacturing support activities.
• Identify innovative solutions and support initiation of process improvements.
• Assist in GMP training of others.
• Perform visual inspection of drug product.

Qualifications

• Bachelor’s degree in a relevant discipline with at least 2 years of relevant experience in cell product GMP manufacturing. A High School diploma with 3+ years of relevant experience will also be considered.
• Experience in iPSC drug product manufacturing is a plus.
• Ability to read and follow manufacturing-related documents including Batch Records, SOPs, Work Instructions and Forms.
• Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced and dynamic environment.
• Familiarity with standard cell culture methods is required.
• Knowledge of cGMP regulations applicable to biologics and cell therapy manufacturing is preferred.
• Must be team oriented and flexible, striving for team success and quality results.
• Visual Acuity Testing required.

Working Conditions

• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
• Will require working with cells and cell lines of human and/or animal origin.
• Will require working with hazardous materials.
• Will require work in controlled and cGMP Manufacturing environments requiring special gowning.
• Evening and weekend work may be required.