Senior Upstream GMP Manufacturing Lead – Cell Culture

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

Benefits offered by this job

Medical, Dental, Vision

401K with match up to 5% plus 3%

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific in Fremont, CA seeks an Upstream Manufacturing Lead. This hands-on floor leader coordinates GMP upstream operations, including media prep, cell culture thaw and expansion, and bioreactor operations, ensuring on-time, compliant execution.

You will train staff, serve as floor SME, perform deviations/CAPAs, support tech transfer, and maintain rigorous safety and quality standards in a fast-paced CDMO environment.

Qualifications

• Bachelor's degree in Life Sciences or related field; or an equivalent combination.
• 5–7 years of biopharma manufacturing experience in upstream mammalian operations.
• GMP training and hands-on experience in aseptic processing and documentation.

Responsibilities

• Leads, coordinates, and executes complex GMP upstream unit operations.
• Leads daily shift execution, prioritizing and coordinating floor activities.
• Primary floor SME; escalates safety, quality, and schedule risks as needed.
• Trains, mentors, and evaluates manufacturing personnel on GMP practices.

Skills

GMP experience

Floor lead

Troubleshooting

Training SME

Cell culture

Documentation

Cross-functional

Problem solving

Education

Bachelor's in Life Sciences

Associate's degree

Tools

UNICORN

PI Historian

DeltaV

Wonderware

EBR/QMS

Job description

Bionova Scientific in Fremont, CA seeks an Upstream Manufacturing Lead. This hands-on floor leader coordinates GMP upstream operations, including media prep, cell culture thaw and expansion, and bioreactor operations, ensuring on-time, compliant execution.

You will train staff, serve as floor SME, perform deviations/CAPAs, support tech transfer, and maintain rigorous safety and quality standards in a fast-paced CDMO environment.