This role reports directly to the Manufacturing Supervisor.

US Citizens or Greencard Holders only

Pay Rate : $25-35 / hr

Location : Los Angeles Metropolitan Area

Responsibilities :

• Perform all tasks associated with the manufacture of clinical product following batch records and SOPs
• Cell culturing and aseptic techniques
• Work as part of a small team to execute GMP runs in close collaboration with Process Development, Facilities and Quality departments
• Assist in the development of standard operating procedures (SOPs), master batch records (MBRs), deviations and change controls
• Ensure right-the-first time performance of all process steps specific to the phase or state of operation, as well as drive the safety-first culture
• Assist with authoring new or revise existing SOPs, MBRs, and other process documents
• Successfully troubleshoot processing and equipment issues
• Daily, real-time review of in-process cGMP documentation for completeness and accuracy
• Assist with change control and investigations required to manage deviations
• Train personnel on applicable procedures and equipment.
• Other duties as assigned

Qualifications :

• Bachelor's degree required in a life science field such as biology, biotechnology, or chemical engineering; Associate's degree for the Technician level
• At least two years of relevant life sciences industry experience; 0-1 years for the Technician level
• Cell therapy-based therapeutics or other cell-based products is a plus
• Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
• Excellent aseptic / sterile techniques and prior experience with cell culture, cell culture equipment
• Must be able to work under aseptic conditions in a class 100 environment

Last updated : 2024-06-04