GMP Upstream Manufacturing Lead—Biologics

Asahi Kasei; Fremont (CA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K (match 5

Paid time off

Annual Bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking an experienced Upstream Manufacturing Lead to manage GMP upstream operations on the floor, including cell culture expansion, media preparation, and bioreactor operations. This role remains hands-on and serves as a floor SME for shift execution, troubleshooting, and escalation.

The Lead will train and mentor manufacturing personnel, coordinate daily activities, and ensure compliance, safety, and on-time production through effective cross-functional

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, or related field.
• Hands-on experience leading and executing mammalian upstream operations in GMP environment.
• Strong knowledge of cGMP and related documentation practices.
• Experience authoring deviation investigations, CAPAs, and change controls.
• Proven trainer/ SME experience on manufacturing floor.

Responsibilities

• Leads GMP upstream unit operations including media prep, cell culture expansion, and bioreactor operations.
• Manages daily shift execution, priorities, and personnel coverage.
• Acts as floor SME, trains and evaluates personnel, and coordinates cross-functional support.
• Escalates safety, quality, and schedule risks and drives timely resolutions.
• Leads deviation investigations, CAPAs, and change controls within scope."
• Collaborates with Quality, Process Development, Validation, Facilities & Engineering, and QC.

Skills

GMP floor leadership

Cell culture operations

Troubleshooting

Deviation investigations

Quality systems

Training/mentoring

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related

Associate’s degree with 7+ years experience

Tools

UNICORN

PI Historian

DeltaV

Wonderware

EBR systems

QMS platforms

Job description

Bionova Scientific LLC in Fremont, CA is seeking an experienced Upstream Manufacturing Lead to manage GMP upstream operations on the floor, including cell culture expansion, media preparation, and bioreactor operations. This role remains hands-on and serves as a floor SME for shift execution, troubleshooting, and escalation.

The Lead will train and mentor manufacturing personnel, coordinate daily activities, and ensure compliance, safety, and on-time production through effective cross-functional