Senior GMP Upstream Manufacturing Lead

Bionova Scientific, Inc.; Fremont (CA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Direct Hire

Medical, Dental, Vision, 401K (match)

Paid time off

Annual Bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA is seeking an Upstream Manufacturing Lead to direct GMP upstream operations on the manufacturing floor. You will act as SME, trainer, and primary contact for shift execution while ensuring safety, quality, and on-time production.

The role requires hands-on biopharma experience, strong GMP knowledge, leadership, and collaboration with QA, Process Development, Validation, and Facilities teams. Competitive compensation and benefits are included.

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering, or related field; 5–7 years of relevant biopharma manufacturing.
• Hands-on experience leading mammalian upstream operations in a GMP environment.
• Strong knowledge of cGMP and documentation, CAPAs, and quality systems.

Responsibilities

• Lead complex GMP upstream unit operations, including cell culture expansion and harvest, with hands-on execution.
• Coordinate shift activities, prioritize work, review production schedules, and ensure effective handoffs.
• Act as floor SME, mentor and train personnel, and escalate risks to management and QA.
• Troubleshoot equipment/process issues and drive CAPAs, deviation investigations, and investigations.
• Author and review GMP/documents, batch records, SOPs, and training materials; support tech transfer and readiness.

Skills

Leadership

GMP knowledge

Cell culture

Troubleshooting

Training/mentoring

Documentation

Problem solving

Education

Bachelor's degree in Life Sciences / Biotechnology

Associate's degree with 7+ years experience

Tools

UNICORN

PI Historian

DeltaV

Wonderware

Job description

Bionova Scientific LLC in Fremont, CA is seeking an Upstream Manufacturing Lead to direct GMP upstream operations on the manufacturing floor. You will act as SME, trainer, and primary contact for shift execution while ensuring safety, quality, and on-time production.

The role requires hands-on biopharma experience, strong GMP knowledge, leadership, and collaboration with QA, Process Development, Validation, and Facilities teams. Competitive compensation and benefits are included.