Tram D. Nguyen

Supporting bulk and aseptic fill operations through process optimization, troubleshooting, and cross-functional leadership. Experienced in project management, investigations, validation, technology transfer, and audits, driving efficiency, compliance, and throughput while mentoring engineers and supporting commercial, R&D, and capital initiatives.

• Executed new equipment commissioning IQ, OQ, PQ validation qualification, ensuring compliance with regulatory requirements, adherence to validated parameters, and FDA guidelines, meeting all safety government guidelines for 100% of equipment.
• Collaborated with cross-functional teams and vendors to install new equipment for aseptic processing, including filling machines, parts washer, and autoclaves, increasing production line speed from 45 vials per minute to 90 to 100 vials per minute.
• Conducted risk assessments and created FMEA documents specific to sterile fill operations, saving the company over $150K in external contractor fees.
• Authored, reviewed, and supported execution of technical reports, Master Batch Records, SOPs, deviations, CAPAs, and quality system documents, resolving all assigned quality issues within an average of 5 days, 50% sooner than the company deadline of 10 days.
• Led and supported process improvement for manufacturing and operations, reducing processing errors, saving the company over $1.2M annually in downtime.

Worked with Supply Operations, Quality Assurance, and Quality Control to develop and establish technical specifications—advanced sterile fill operations through technology transfer, capital projects, and continuous improvement initiatives.

• Partnered across functions to resolve bottlenecks, optimize processes, and introduce innovative solutions that enhanced efficiency, throughput, and regulatory readiness, reducing the defect rate from 5% to 2% or less per batch.

Specialized in sterile fill operations, leading troubleshooting, process optimization, and capital projects. Led equipment reliability investigations and compliance, drove cross-functional improvements, technology transfer, and regulatory audit readiness, and ensured efficient, cGMP-compliant manufacturing performance.

• Launched a new vial size, increasing line speed up to 100 vials per minute, and manufacturing capacity over 1.4M EXPAREL vials annually.

• Led fill line operations, projects, and cross-functional teams. Provided subject matter expertise for sterile filling equipment, driving efficiency, compliance, and throughput while managing investigations, CAPAs, and audits to ensure operational excellence and reliable drug supply.

• Provided fill line troubleshooting, equipment reliability, and process optimization. Supported root cause investigations, validation, and change controls, delivering data-driven solutions to increase uptime, streamline operations, and maintain full cGMP compliance.

• Assisted Validation and Project Managers in finalizing Summary Reports for The Parts Washer and Temperature Control Cycle Development. The CIP and SIP Development for Cathflo Portable Formulation Tank. Stopper and Cap Machinability Assessment of Filler Machine. Liophilizer Cycle Development for Capacity.

• Optimized NaHA sterilization, concentration (UF, SC, DE), and stability testing to improve yield and efficiency. Integrated processes with formulation systems. Directed equipment installation and SOP development. Executed fill-weight studies leveraging SPC tools to enhance capability, reduce variability, and ensure compliance.

Directed process development and technology transfer of corrosive gas purifiers from R&D to production, driving yield improvements and cost savings. Designed gas delivery systems, validated processes, and ensured compliance with safety standards.

• Drove 100% yield improvements for the production of corrosive gas purification.

Planned and validated gas purification experiments, designed gas delivery systems, and ensured safety compliance. Supported R&D, troubleshooting, and customer needs while successfully managing vendors and equipment.

• Developed and delivered a gas purification system for corrosive gases, achieving a substantial safety improvement from an acidity level of 100% to 60%.