Director Manufacturing Bulking

Tolmar Careers • Windsor, CO

10d

About The Position

The Director Manufacturing - Bulking provides end-to-end leadership and accountability for bulking operations at the Cornerstone site, covering Paliperidone, Syringe A, Syringe B, and Polymer. The 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 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.

The position leads operational strategy and daily execution, maintains a strong quality and compliance culture, supports technical and process improvements, develops manufacturing teams, and manages operating and capital resources. It also represents Manufacturing in relevant inspections, audits, and governance reviews. The role is expected to operate in alignment with Tolmar’s Core Values: Center on People, Are Proactive & Agile, Act Ethically, Constantly Improve, and Are Accountable.

Working conditions are normal for an office environment. Some evenings and weekends may be necessary. The position is bonus eligible, with a stated pay range of $215,000 to $240,000 depending on experience. Tolmar describes its compensation programs as including market-based base pay and a strong benefits package; further benefits information is linked in the posting.

Requirements

• Bachelor’s degree in engineering, biological sciences, chemistry, pharmaceutical sciences, or another STEM discipline.
• Ten or more years of progressive experience in pharmaceutical, biotechnology, medical-device, or similarly regulated manufacturing, including substantial production-operations experience.
• Significant experience in sterile or aseptic manufacturing operations.
• 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.
• 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, including the ability to balance patient safety, compliance, supply, and business needs.
• Effective communication and ability to influence senior leaders, technical partners, and frontline teams, and 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.

Nice To Haves

• An advanced degree.
• Experience with formulation, compounding, bulking, filling, or related processing.

Responsibilities

• Provide strategic and day-to-day leadership for Cornerstone bulking operations supporting Paliperidone, Syringe A, Syringe B, and Polymer.
• Own production-schedule execution across the bulking portfolio by aligning labor, equipment, materials, training, and cross-functional support with 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 follow approved procedures, aseptic practices, contamination-control requirements, hold-time requirements, and process controls.
• Maintain a strong quality and compliance culture aligned with cGMP, data integrity, contamination-control, safety, and regulatory requirements.
• Provide manufacturing leadership for deviations, investigations, risk assessments, change controls, and CAPA, emphasizing 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 concerning 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 to reduce recurring losses and reliance on reactive support.
• Lead, coach, and develop managers, supervisors, technical specialists, leads, and operators, establishing accountability and a pipeline of manufacturing leadership talent.
• Ensure training and qualification systems prepare employees to perform complex and critical tasks safely, correctly, and consistently before working independently.
• 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 Lean, Six Sigma, problem-solving, standard-work, and data-driven methods to reduce losses, variability, cycle time, and waste.
• Identify operational, compliance, supply, and capability risks and establish prioritized mitigation plans with clear owners and timelines.
• Lead cross-functional initiatives to 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.

Benefits

• The position is bonus eligible.
• Tolmar describes its benefits package as strong and provides a link to further benefits information; individual benefits are not specified in the posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Director