Manufacturing Associate, Downstream

Company

Bionova Scientific LLC, a subsidiary of Asahi Kasei Medical, is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes.

Position Summary

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 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 and support GMP and manufacturing activities.

• Execute, with oversight of qualified staff, complex unit operations including chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
• Maintain own training within compliance.
• Support 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.
• Document work according to cGMP and cGDP.
• Adhere to established regulations and follow cGMP established by site.
• Maintain cleanroom standards, practices, and housekeeping according to SOPs.
• Recognize minor equipment issues and notify leads/managers immediately.
• Contribute to quality activities such as investigations, area walk‑throughs, and support authoring deviations, CAPA, change control.
• Other duties as assigned and flexibility to work in shifts.

• This position requires working in a lab/office setting with walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift or move up to 20 pounds independently.

• Associate degree with 1–2 years of relevant experience, or a combination of experience and an advanced degree, preferably in a biopharma manufacturing role.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing.
• Working knowledge of industry‑standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc.) and equipment (GE AKTAs, disposables).
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian).
• Creative thinker capable of identifying 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 manage multiple projects simultaneously.

The base compensation range for this role is between $25 and $30 an hour, though actual compensation may vary depending on experience and qualifications.

Bionova offers health benefits at a subsidized rate. Coverage includes healthcare, dental, and vision insurance. Life insurance and disability program are 100% covered. Retirement plan (401K) with up to 8% 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.