Upstream Manufacturing Lead

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

• 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 cause analyses, impact assessments, CAPAs, and change controls within assigned scope and drives actions through timely resolution.

Authors, reviews, and approves, as authorized, GMP and technical documentation including batch records, SOPs, technical protocols/reports, risk assessments, training materials, equipment URSs, and tech transfer documentation. Performs Manufacturing review/verification of executed records when qualified and assigned and supports timely record closure.

Leads or coordinates pre-campaign and production readiness activities, including personnel and training readiness, EBR/batch record readiness, equipment and facility readiness, materials and consumables, sampling requirements, and production schedule alignment.

Supports and leads manufacturing activities associated with technology transfer, engineering and pilot-scale runs, non-GMP/tox material generation, equipment qualification and validation execution, PPQ support, facility/start-up readiness, and implementation of new equipment or manufacturing systems.

Assesses the impact of issues, deviations, and non-conformities on product quality, patient safety, process performance, and project milestones; applies sound technical judgment, escalates appropriately, and drives cross-functional resolution.

Evaluates and recommends new technologies, equipment, workflows, and process improvements to improve operational efficiency, capacity, reliability, and cell culture capability. Leads or contributes to Lean, 5S/6S, and continuous-improvement initiatives.

Collaborates with Quality, Process Development, Validation, Facilities & Engineering, Warehouse/Materials, QC, and other functions to coordinate raw materials, utilities, testing, documentation, maintenance, equipment readiness, validation, and production scheduling.

Maintains personal GMP training compliance and models and reinforces expected GMP behaviors, real-time documentation, traceability, aseptic technique, cleanroom standards, housekeeping, and accountability on the manufacturing floor.

Supports client audits, regulatory inspections, internal audits, and area walk-throughs as a Manufacturing SME; provides clear, accurate responses and supports timely resolution of observations and follow-up actions.

Performs other duties as assigned to ensure safe, compliant, and effective manufacturing operations.

Working Conditions

This position works in a cleanroom/manufacturing and office environment. The role requires walking, standing, stooping, kneeling, bending, and crouching for extended periods.

Must be able to gown and work within a controlled/cleanroom environment and occasionally lift and/or move up to 20–25 pounds independently.

Flexibility with work hours to meet production schedules, including shift coverage, evenings, weekends, and holidays, as business needs require.

Qualifications

Bachelor's degree in Life Sciences, Biotechnology, Chemical/Biochemical Engineering, or related field with 5–7 years of relevant biopharma manufacturing experience; OR Associate's degree with 7+ years of directly relevant experience. Equivalent combinations of education, training, and experience will be considered.

Demonstrated hands-on experience leading and executing mammalian upstream operations in a GMP environment, including cell culture expansion, cell banking, and single-use and/or stainless-steel bioreactor operations (e.g., seed train and production bioreactors).

In-depth working knowledge of mammalian cell culture principles, upstream process performance, aseptic processing practices, process monitoring, and troubleshooting.

Strong working knowledge of cGMP and cGDP requirements as they apply to manufacturing operations, documentation, investigations, deviations, CAPAs, change control, and audit/inspection readiness.

Demonstrated experience authoring, reviewing, and/or executing batch records, SOPs, technical protocols, risk assessments, and quality records in a regulated environment.

Proficiency with process monitoring and equipment software (e.g., UNICORN, PI Historian, DeltaV, Wonderware, or similar); experience with electronic batch record (EBR) a