Upstream Manufacturing Lead

Location: Fremont, CABenefitsDirect Hire

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 2025 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 57 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) and quality management system (QMS) platforms preferred. Demonstrated experience as a qualified trainer, SME, shift lead, or floor lead, including assigning/coordinating work, mentoring personnel, assessing competency, and supporting effective shift execution. Strong root-cause, investigational, and problem-solving skills with demonstrated experience leading or authoring deviations, CAPAs, change controls, and technical impact assessments. Demonstrated ability to independently evaluate technical and operational situations, prioritize competing needs, make sound floor-level decisions within scope, and escalate appropriately in a fast-paced CDMO environment. Strong leadership, organizational, written, and verbal communication skills with the ability to influence without formal authority and work effectively across diverse cross-functional teams. Demonstrated commitment to Safety, Quality, accountability, documentation discipline, 5S/6S, GMP culture, coaching, and continuous improvement.

Compensation: The base compensation range for this role is $45-50 an hour. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.