Job Details
The Manufacturing Technician/Associate is responosible for ensuring the onstime delivery of quality biopharmaceutical products and supporting cell culture manufacturing. 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