The Manager, Manufacturing Operations provides on-site leadership and oversight for production and quality control (QC) activities to support the safe, compliant, efficient, and consistent manufacture and testing of products at the company's site. This role leads personnel within the relevant function, establishes operational priorities, manages resources and capacity, and drives performance against quality, delivery, cost, and productivity objectives. The Manager partners cross-functionally with Quality Assurance, Supply Chain, Logistics, and other functions to maintain effective operations, resolve production and quality-related issues, and drive continuous improvement. The role is responsible for ensuring manufacturing and QC activities are performed in accordance with established procedures, applicable quality requirements, and organizational standards. Lead Manufacturing Operations, including production and Quality Control (QC), ensuring biological products are manufactured and tested safely, efficiently, and in accordance with approved procedures, specifications, and applicable quality requirementsLead, develop, and manage personnel under overall remit, establishing priorities, allocating resources, managing performance, developing technical and business capabilities, and maintaining appropriate training and qualificationPlan and coordinate production and QC activities to meet manufacturing schedules, testing and product-release requirements, capacity needs, and customer commitmentsEnsure manufacturing and QC activities and records comply with the Quality Management System (QMS), ISO requirements, approved procedures, good documentation practices, and applicable safety and regulatory requirementsOversee QC testing and associated laboratory activities, ensuring materials and products are appropriately tested, documented, controlled, and traceable throughout manufacturing operationsLead and support investigations of manufacturing and QC issues, including deviations, nonconformances, testing issues, and process failures; partner with Quality Assurance on root-cause analysis and corrective and preventive actions (CAPA)Drive operational excellence and continuous improvement by monitoring quality, productivity, yield, testing, and delivery performance and implementing improvements to processes, methods, equipment, workflows, and capacityPartner cross-functionally with Quality Assurance and other technical and business functions to support product introductions, process and method transfers, change control, validation and qualification activities, audits, inspections, and ongoing product and process improvementChampion site culture and employee engagement, modeling organizational values and actively supporting initiatives that strengthen collaboration, communication, recognition, inclusion, and employee connection across functionsPerform other duties as assigned or required to meet business needs
