Director Manufacturing Bulking

Purpose and Scope The Director Manufacturing - Bulking provides end-to-end leadership and accountability for bulking operations at the Cornerstone site, with Paliperidone, Syringe A, Syringe B, and Polymer within scope. This role is responsible for safe, compliant, reliable, and efficient execution across aseptic and non-aseptic bulking activities, including schedule delivery, product quality, process performance, workforce capability, and continuous improvement. The Director leads through managers and frontline leaders and partners closely with Quality, Engineering, Maintenance, MS&T, Validation, Supply Chain, and other functions to strengthen process control, resolve issues, build technical capability, and support sustainable growth. Essential Duties & Responsibilities Operational Leadership Provide strategic and day-to-day leadership for Cornerstone bulking operations supporting Paliperidone, Syringe A, Syringe B, and Polymer products. Own execution of the production schedule across the bulking portfolio, aligning labor, equipment, materials, training, and cross-functional support to meet business commitments. Establish clear operating standards and performance management routines across shifts, including tiered accountability, escalation, shift handoffs, and leader presence on the floor. Monitor and improve safety, quality, delivery, cost, capacity, yield, cycle time, right-first-time, deviation, and equipment-performance metrics. Ensure operations are inspection-ready and executed in accordance with approved procedures, aseptic practices, contamination-control requirements, and applicable hold-time and process controls. Compliance & Regulatory Maintain a strong quality and compliance culture across bulking operations and ensure alignment with cGMP, data integrity, contamination-control, safety, and regulatory requirements. Provide manufacturing leadership for deviations, investigations, risk assessments, change controls, and CAPA, with emphasis on timely containment, scientifically sound root cause, and sustainable corrective actions. Partner with Quality to ensure batch documentation, production records, and quality-system actions are accurate, timely, and inspection-ready. Represent Manufacturing during health authority inspections, customer audits, and internal governance reviews for matters related to bulking operations. Technical & Process Support Partner with Engineering, Maintenance, MS&T, Validation, and Quality to improve process robustness, equipment reliability, contamination control, and technical performance. Support technology transfers, process scale-up, validation, equipment qualification, and implementation of new products, processes, and manufacturing technologies. Ensure appropriate technical assessment and change control for process, equipment, material, and site-transfer changes. Build sustainable troubleshooting, standard work, and equipment-care practices that reduce recurring losses and reliance on reactive support. People & Team Development Lead, coach, and develop managers, supervisors, technical specialists, leads, and operators, establishing clear accountability and a strong pipeline of manufacturing leadership talent. Ensure training and qualification systems prepare employees to execute complex and critical tasks safely, correctly, and consistently before independent performance. Strengthen technical depth across shifts through structured coaching, cross-training, succession planning, and development of process and equipment expertise. Foster a culture of safety, quality, ownership, collaboration, disciplined execution, and timely escalation. Continuous Improvement & Strategy Develop and execute the bulking operating strategy, including capacity, staffing, shift structure, asset utilization, process capability, and readiness for future demand. Lead continuous improvement using practical Lean, Six Sigma, problem-solving, standard-work, and data-driven methods to reduce losses, variability, cyc…

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