Upstream Manufacturing Associate

Bionova Scientific • Fremont, CA

402d • $52,000 - $62,400

About The Position

The Upstream Manufacturing Associate at Bionova Scientific LLC plays a crucial role in the Manufacturing Operations at the B1 site. This position involves hands-on execution of complex experiments and ownership of various projects related to troubleshooting, system implementation, facility buildout, and tech transfers in a GMP multi-product manufacturing environment. The associate will work closely with qualified staff to execute unit operations and maintain compliance with established regulations.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 0+ years of relevant experience in biopharma manufacturing or a combination of experience and relevant degree.
• Understanding of mammalian cell culture performance and bioreactor operations (mandatory for Senior MFG Associate).
• Working knowledge of cGMP compliance related to manufacturing processes.
• Experience with process monitoring software and equipment software (e.g., UNICORN, Pi Historian) is preferred.
• Strong analytical skills and attention to detail.

Nice To Haves

• Experience in biopharma manufacturing roles.
• Creative thinking to identify efficient methods for addressing issues.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Execute complex unit operations including media preparation, cell culture thaw, expansion, and end of production banking.
• Operate single-use bioreactors and perform process monitoring and harvest operations.
• Maintain analytical equipment, stock consumables, and manage expired reagents.
• Train other GMP associates and maintain personal training compliance.
• Support equipment troubleshooting and assist in Cell Inoculum and Downstream operations.
• Author, review, and approve technical documents such as tech transfer protocols, experimental plans, and manufacturing SOPs.
• Document work according to cGMP and cGDP standards and maintain cleanroom practices.
• Contribute to quality activities such as investigations and author deviations, CAPA, and change control.

Benefits

• 401(k) with up to 8% employer match
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Paid time off (up to two weeks)
• 10 paid holidays and 5 sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree