Upstream Manufacturing Lead

About the role

The Upstream Manufacturing Lead is a GMP‑qualified floor leader in the Cell Culture/Manufacturing group at Bionova Scientific’s Fremont site. Reporting to the Manufacturing Supervisor or Associate Director, the Lead drives day‑to‑day upstream operations while remaining hands‑on in complex bioprocess activities.

Key responsibilities

• Lead and coordinate complex GMP upstream unit operations, including media preparation, cell thaw/expansion, cell banking, and bioreactor runs (single‑use and stainless‑steel).
• Assign and manage shift activities, ensure operational readiness, and facilitate effective handoffs between teams.
• Act as the primary point of contact for safety, quality, compliance, equipment, staffing, and schedule risks when supervisors are unavailable.
• Provide OJT training, mentor staff, and maintain training matrices to ensure competency.
• Lead troubleshooting, deviation investigations, root‑cause analyses, CAPAs, and change controls.
• Author and review GMP documentation such as batch records, SOPs, technical protocols, and risk assessments.
• Support technology transfer, pilot‑scale runs, equipment qualification, and continuous‑improvement initiatives.

Required profile

• Bachelor’s degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering or related field with 5–7 years of biopharma manufacturing experience (or Associate’s degree with 7+ years).
• Hands‑on experience leading mammalian upstream operations in a GMP environment, including cell culture expansion, banking, and bioreactor operation.
• Strong knowledge of cGMP/cGDP requirements, documentation, investigations, and audit readiness.
• Proven ability to train personnel, manage shift execution, and drive cross‑functional collaboration.

Required skills

• GMP compliance
• Mammalian cell culture
• Bioreactor operation (single‑use and stainless‑steel)
• Process monitoring software (UNICORN, PI Historian, DeltaV, Wonderware)
• Electronic batch record (EBR) systems
• Quality Management System (QMS) platforms

What we offer

• Direct‑hire permanent position
• Medical, Dental, Vision benefits
• 401K match up to 8%
• Paid time off and annual bonus eligibility