ENGINEERING MANAGER
Modality Solutions

I specialize in advising biopharmaceutical companies on their regulatory strategies related to supply chain and packaging. I advise clients on their early stage mAbs, gene therapies, and cell therapies to ensure compliance and smooth ramp up to pivotal and eventual commercialization phases. I bring nearly a decade of experience in the biopharmaceutical industry and have overseen the commercial approval of more than 30 unique biologics, including three cell therapies.

ENGINEERING MANAGER
Modality Solutions

I am an expert in cold chain engineering and biopharmaceutical shipping validation and am passionate about developing risk-based validation strategies, qualifying thermal packaging, and designing transportation studies, and have been involved in over 30 commercial drug approvals. I serve as the co-chair for the Cold Chain Working Group within the International Society of Cell and Gene Therapies (ISCT). Additionally, I am a active member of the International Safe Transit Association (ISTA) Pharma Committee.

TECHNICAL OPERATIONS MANAGER
Modality Solutions

My specialty is developing testing strategies to assess drug product robustness and packaging performance through global distribution to support shipping validation efforts and regulatory filings. I have nearly a decade of experience designing and executing studies for 100+ approved products across all temperature ranges, packaging types, and global markets.

PRINCIPAL ENGINEER
Modality Solutions

I specialize in logistics network design, cold chain systems, and regulatory compliance for pharmaceutical products, including new drug applications, BLAs, and cell therapies. I have extensive experience in clinical trial operations, conducting risk assessments, SOP development, and cold chain consulting services, and have worked on projects including Ebola vaccine trials and the COVID-19 clinical trial project across multiple countries.