Associate Scientist II, US

Asahi Kasei•Fremont, CA

1d•Onsite

About The Position

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Position Summary: The Sr Associate Scientist, Cell Culture will actively contribute to the develop and execute cell culture processes and technology transfer projects. As part of the Cell Culture group, you will have opportunities to work on and take ownership of a 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 position performs professional planning, coordination, analysis, and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. 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

BS in Engineering, Life Sciences, or related discipline with 2-4 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
Must have bioreactor operations experience.
In-depth understanding of mammalian cell culture performance is required.
Hands-on experience in running, developing, and validating processes
Experience in process development, process characterization and/or tech. transfer processes.
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
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.
Ability to independently evaluate technical situations and propose potential solutions.
Must have the ability to work efficiently in a fast-paced environment.
Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

Responsibilities

Executes 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 PD associates upon completion of trainer qualification.
Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation.
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.
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 supervisors and leads 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.
Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling
Present during inspections from regulatory agencies and client audits as needed.