Delivering Operational Excellence

⭐Transforming a Construction Space into a Qualified GMP Facility

S

The new facility needed to be transformed from a construction zone into a fully qualified GMP cleanroom for COVID-19 vaccine production.

T

Lead the cleaning and EM PQ effort under tight timelines and evolving requirements.

A

•         Broke down a massive, ambiguous scope into clear, executable tasks.

•         Coordinated cross‑functional teams across EM, Operations, and Facilities.

•         Managed OOS results, HVAC issues, and material shortages.

•         Personally supported floor cleaning to keep the schedule on track.

R

•         Successfully qualified the facility on time.

•         Achieved excellent EM results and full compliance.

•         Enabled the site to progress to GMP manufacturing of COVID‑19 vaccine.

⭐ Driving Global Network Support in Ireland

S

Commercialization Facility startup faced 640 open engineering issues and lacked a structured workflow for PPQ readiness.

T

Provide network support, establish governance, and accelerate issue closure.

A

•         Built a workflow for issue reporting, compliance risk assessment, and Tier escalation.

•         Facilitated alignment across multiple stakeholders and SMEs.

•         Provided daily coaching and visibility tools to drive accountability.

R

•         Closed 503 of 640 issues.

•         Remaining issues were reclassified into CI or change control.

•         Site leadership recognized the impact and adopted the workflow as standard.

⭐ Increasing Influenza Seed Yields by 60%

S

The influenza seed development process was producing suboptimal yields.

T

Improve yield for the upcoming pandemic strain.

A

•         Eliminated antibiotic addition in early passages.

•         Streamlined BPRs and closed compliance gaps.

•         Led cross‑functional collaboration with Manufacturing Technology.

R

•         Achieved 60% yield improvement.

•         Strengthened compliance and reduced process variability.

•         Contributed to successful pandemic response readiness.