Director, Bulking Operations & Process Excellence

Tolmar-7; Windsor (CO); In loco; USD 215.000 - 240.000; Tempo pieno

Descrizione del lavoro

Tolmar seeks a Director of Manufacturing - Bulking to lead Cornerstone bulking operations (Paliperidone, Syringe A/B, Polymer) across aseptic and non-aseptic processes. You will drive schedule delivery, product quality, and continuous improvement while partnering with Quality, Engineering, MS&T, Validation, and Supply Chain.

The role emphasizes strategic leadership, safety, and regulatory readiness, with accountability for budgeting and workforce development to sustain growth and reliability.

Competenze

• Bachelor’s degree in engineering, biological sciences, chemistry, pharmaceutical sciences, or another STEM; 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; 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.

Mansioni

• 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 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 compliant with procedures, aseptic practices, contamination‑control requirements, hold‑time and process controls.
• Represent Manufacturing during health authority inspections, customer audits, and internal governance reviews for bulking operations.
• Lead continuous improvement using Lean, Six Sigma, problem‑solving, standard‑work, and data‑driven methods to reduce losses, variability, cycle time, and waste.
• Develop operating and capital budgets for the bulking organization and align headcount with production demand and business priorities.
• Develop business cases and recommendations for equipment, automation, facility, staffing, and process investments.
• Perform other duties as assigned.

Conoscenze

Leadership

Cross-functional collaboration

Strategic planning

Formazione

STEM degree

10+ years regulated manufacturing experience

Strumenti

Lean/Six Sigma

Descrizione del lavoro

Tolmar seeks a Director of Manufacturing - Bulking to lead Cornerstone bulking operations (Paliperidone, Syringe A/B, Polymer) across aseptic and non-aseptic processes. You will drive schedule delivery, product quality, and continuous improvement while partnering with Quality, Engineering, MS&T, Validation, and Supply Chain.

The role emphasizes strategic leadership, safety, and regulatory readiness, with accountability for budgeting and workforce development to sustain growth and reliability.