Manufacturing Associate

Asahi Kasei•Fremont, CA

1d•Onsite

About The Position

The Manufacturing Associate will support GMP and manufacturing activities. As part of the Cell Culture/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, systems and tech transfers of processes into a GMP mulit-product manufacturing facility. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.

Requirements

Associate degree with 0-2 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
Demonstrate ability to work independently and on cross-functional teams.
Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
Strong analytical skills and attention to detail.
Flexible mindset for a dynamic environment.

Nice To Haves

Bioreactor operations, understanding of mammalian cell culture is preferred.
Understanding process monitoring software and equipment software (UNICORN, Pi Historian), cGMP compliance as it pertains to procedures, processes, and manufacturing is preferred.

Responsibilities

Performs complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.
Support activities such as maintenance of analytical equipment, stocking of consumables.
Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification.
Support in equipment troubleshooting, pilot scale material generation, GMP upstream manufacturing activities.
Adheres to established regulations and follows cGMP and cGDP established by site.
Maintain cleanroom standards and housekeeping according to SOPs.
Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope.
Notify leads/managers of issues and discrepancies immediately.
Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
Other duties as assigned.