Senior GMP Upstream Lead — Cell Culture

Celgard; 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 Upstream Manufacturing Lead to oversee GMP upstream operations on the cell culture floor. The role combines hands-on manufacturing with SME duties, training, and coordination of shift activities.

The candidate will lead troubleshooting, deviations, and CAPAs, ensuring quality, safety, and on-time production while collaborating with cross-functional teams.

Qualifications

• Hands-on GMP upstream operations including cell culture expansion.
• Experience with viral or recombinant protein process steps in GMP.
• Familiarity with batch records and quality systems.

Responsibilities

• Leads GMP upstream unit operations and ensures on-time execution.
• Manages shift execution, priorities, and cross-functional coordination.
• Acts as SME for troubleshooting, training, and escalation.
• Authors deviation investigations, CAPAs, and change controls.
• Supports technology transfer and process validation activities.

Skills

GMP operations

Cell culture expansion

Bioreactor operations

Troubleshooting

Training/Mentoring

Quality systems

Education

Bachelor’s degree in Life Sciences or related field

Associate’s degree with 7+ years

Tools

UNICORN

PI Historian

DeltaV

Wonderware

Job description

Bionova Scientific LLC in Fremont, CA is seeking an Upstream Manufacturing Lead to oversee GMP upstream operations on the cell culture floor. The role combines hands-on manufacturing with SME duties, training, and coordination of shift activities.

The candidate will lead troubleshooting, deviations, and CAPAs, ensuring quality, safety, and on-time production while collaborating with cross-functional teams.