Director Manufacturing Bulking

Tolmar•Windsor, CO

11d•$215,000 - $240,000•Onsite

About The Position

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.

Requirements

Strong knowledge of pharmaceutical manufacturing operations, including aseptic processing, contamination control, and cGMP requirements.
Ability to lead a diverse portfolio of complex manufacturing processes while establishing consistent standards across products, teams, and shifts.
Demonstrated success leading and developing managers and frontline teams in a regulated manufacturing environment.
Strong understanding of process control, equipment reliability, validation, technology transfer, and manufacturing scale-up.
Ability to interpret production, quality, capacity, and financial data and translate it into clear priorities and executable plans.
Proficiency in risk assessment, root cause analysis, deviation investigation, CAPA, and change management.
Track record of improving safety, quality, delivery, cost, workforce capability, and operational performance through disciplined execution.
Strong judgment and decision-making skills, including the ability to balance patient safety, compliance, supply, and business needs.
Effective communicator with the ability to influence senior leaders, technical partners, and frontline teams and to represent the function during audits and inspections.
Proven ability to lead cross-functional work with Quality, Engineering, Maintenance, MS&T, Validation, Supply Chain, and Regulatory partners.
Working knowledge of Lean, Six Sigma, tiered management, standard work, or comparable continuous-improvement systems.
Strategic, hands-on, and adaptable leadership style suited to a fast-paced environment with changing priorities.
Bachelor’s degree in engineering, biological sciences, chemistry, pharmaceutical sciences, or another STEM discipline required; advanced degree preferred.
Ten or more years of progressive experience in pharmaceutical, biotechnology, medical-device, or similarly regulated manufacturing, including substantial experience in production operations.
Significant experience in sterile or aseptic manufacturing operations required; experience with formulation, compounding, bulking, filling, or related processing strongly preferred.
Five or more years of people-leadership experience, including leadership of leaders or multi-shift manufacturing teams.
Demonstrated experience improving operational performance, building workforce capability, and leading cross-functional change in a regulated environment.

Nice To Haves

advanced degree preferred

Responsibilities

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.
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.
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.
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.
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, cycle time, and waste.
Proactively identify operational, compliance, supply, and capability risks and establish prioritized mitigation plans with clear owners and timelines.
Lead cross-functional initiatives that improve reliability, right-first-time performance, sterility assurance, scalability, and business continuity across the bulking portfolio.
Develop and manage operating and capital budgets for the bulking organization.
Align headcount, shift coverage, training capacity, and technical support with production demand and business priorities.
Develop business cases and recommendations for equipment, automation, facility, staffing, and process investments.
Perform other duties as assigned.