Manufacturing Associate, Downstream - Temporary and Full Time

Asahi Kasei•Fremont, CA

7d•$25 - $30•Onsite

About The Position

The Manufacturing Associate will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP and manufacturing activities.

Requirements

Associate degree with 1-2 years of relevant experience, or combination of experience or relevant advanced degree, preferably in biopharma manufacturing role.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing, preferrable
Working knowledge of industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables), preferrable
Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
Creative thinker that can identify better and more efficient methods to address issues and gaps
Demonstrate ability to work independently and on cross-functional teams
Ability to prioritize assignments and to manage multiple projects simultaneously.

Responsibilities

Execute, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
Maintain own training within compliance.
Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
Author/review/approve technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Maintain cleanroom standards, practices, and housekeeping according to SOPs.
Recognize any minor issues from the equipment and 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 and flexible to work in shifts