Manufacturing Associate - Upstream

Asahi Kasei•Fremont, CA

3d•$25 - $30•Onsite

About The Position

The Manufacturing Associate will actively contribute to the manufacturing projects at the Bionova Scientific West Warren site. As part of the Cell Culture/Manufacturing group, you will have opportunities to work on wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP mulit-product 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

Minimum of Associate degree with 1-2 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
Must have bioreactor operations experience.
Understanding of mammalian cell culture performance is required.
Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
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 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.
Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

Responsibilities

Executes with oversight of qualified staff 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.
Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.
Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification.
Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities.
Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, 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 any affiliated documentation and take appropriate corrective action within scope.
Notify leads/managers of issues and discrepancies immediately.
Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
Evaluate new technologies and innovations to improve operational efficiency or expand cell culture capabilities.
Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
Other duties as assigned to ensure appropriate compounding practices