Manufacturing Associate position at Asahi Kasei.| United States of America

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Asahi Kasei Manufacturing Associate

Experience: 2-years

Pattern: Full time

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Associate

Fremont, CA....United States of America

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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. Company: Bionova Scientific LLC Job Description: Position Summary: 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. Essential Duties and 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. Working Conditions: This position requires work in a manufacturing plant. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40 pounds independently. Qualifications Associate degree with 0-2 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role. 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. 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. Ability to work shift hours to meet business needs, including weekends and holidays, as needed. Compensation Range: The base compensation range for this role is between $30 and $32 an hour. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

Manufacturing Associate job opportunity at Asahi Kasei.

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