GMP Manufacturing Associate (Biologics, cell culture or protein production)

100% ONSITE IRVINE CA

PAY:$30-$33/HR

REQUIRED:

• BS/MS in Bioengineering, Biological Engineering or Biotechnology
• Internship/Co-op experience with GMP/cGMP cell culture manufacturing processes
• CAPAs, Batch record review in biologics production environment
• pharmaceutical/biotech biologics production required

Job Description:

Performs functions associated with cGMP biologics manufacturing operations within the production facility, including working with other operations personnel in equipment set-up and batch processing. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Works with Quality, Maintenance, Warehouse, Documentation and Materials Management departments to execute the production plan. Assists in developing procedures to control or modify the manufacturing process.

Responsibilities

•Cell culture (from vial thaw to production scale).

•Column chromatography.

•Tangential flow filtration

•Sampling of in process and raw materials.

•Running glass washer / autoclave.

•Buffer / media preparation.

•Equipment preparation (CIP / SIP).

•Maintaining inventory levels.

Half the job is on the production floor gowned up / the other half of the time will be documentation.

They use Veeva One Vault and SAP for documentation - this is preferred not required

Any LIMS or electronic batch record review preferred

Day to Day: running filtration, AKTA, working collaboratively with peers to update batch records

Must have the ability to collaborate with teams

This facility is a BL level III rating (basically the most intense GMP type of facility around) - so the manager is VERY particular about an individual coming from a biologics production environment (cell culture or protein production)