Upstream Manufacturing Lead

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.

Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

The Upstream Manufacturing Lead is an experienced, GMP-qualified, non-managerial floor leader within the Cell Culture/Manufacturing group at the Bionova Scientific Fremont site. This role leads and coordinates day-to-day upstream manufacturing execution while remaining a hands-on contributor in complex GMP operations. The Lead serves as a floor subject matter expert (SME), qualified trainer, and primary point of contact for shift execution, personnel coordination, troubleshooting, and escalation when the Manufacturing Supervisor or Associate Director is unavailable.

The role exercises sound technical and operational judgment, promotes a strong Safety and Quality culture, and drives compliant, on-time execution of manufacturing activities.

Location :
Fremont, CA

Benefits

• Direct Hire
• Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)
• Paid time off
• Annual Bonus eligible

Essential Duties and Responsibilities

• Leads, coordinates, and executes complex GMP upstream unit operations, including media/solution preparation, cell culture thaw and expansion, cell banking, single-use and stainless-steel bioreactor operations, in-process sampling, process monitoring, and harvest.

• Leads daily shift execution by assigning and coordinating floor activities, confirming priorities and personnel coverage, reviewing the production schedule and operational readiness, and ensuring effective shift handoffs and communication between outgoing and incoming teams.

• Serves as the primary Manufacturing floor point of contact when the Manufacturing Supervisor or Associate Director is unavailable; escalates Safety, Quality, compliance, equipment, staffing, and schedule risks promptly and coordinates appropriate cross-functional support.

• Exercises stop-work authority when an activity presents a potential Safety, Quality, compliance, or product-impact concern and ensures appropriate escalation to Manufacturing Management and Quality, as applicable.

• Serves as a qualified OJT trainer and GMP floor SME; trains, mentors, coaches, and evaluates competency of Manufacturing personnel on unit operations, equipment, aseptic practices, GMP documentation, and applicable procedures. Supports training matrix maintenance, identification of training gaps, and personnel qualification in accordance with site procedures.

• Leads manufacturing troubleshooting and provides technical direction for equipment and process issues. Leads or authors deviation investigations, root…