Upstream Manufacturing Associate
Bionova Scientific LLC

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:

Company Summary:

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.

Position Summary:
The Senior Upstream MFG Associate / Upstream MFG Associate will actively contribute to the Manufacturing Operations at the Bionova Scientific B1 site. As part of the Manufacturing 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, facility buildout, and tech transfers of processes into a GMP multi-product manufacturing facility. The role will 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, Deviation Initiation, Investigation, etc.), equipment validation execution support and single-use assembly design.

Essential Duties and 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.
• Support in Cell Inoculum and Downstream operations.
• 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 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 to ensure appropriate compounding practices

Working Conditions:

• This position requires work in GMP Production Plant with gowning requirements. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications

• BS in Engineering, Life Sciences, or related discipline with 0+ years of relevant experience, or combination of experience and relevant degree, preferably in biopharma manufacturing role.
• Bioreactor operations experience and understanding of mammalian cell culture performance is a plus for a MFG Associate.
• Bioreactor operations experience and understanding of mammalian cell culture performance is a must for a Senior MFG Associate.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian) preferably.
• 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.

Compensation Range: The base compensation range for this role is between $25 and $30 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.

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