Precision in the lab.
Discipline in the quality system.

I've spent more than two decades inside the pharmaceutical and biotechnology industry — first as an analytical scientist developing and validating the methods that determine whether a product meets specification, and later as the manager and director accountable for the quality systems that govern entire manufacturing and laboratory operations.

My career began at Eli Lilly, where I spent fifteen years developing and transferring analytical methods across global manufacturing sites. From there, my responsibilities widened into quality control leadership at Baxter Healthcare, Pfizer, and Coldstream Laboratories; QC management at Adello Biologics; manufacturing-site quality at Johnson & Johnson; and, as Director of Quality at Indiana Botanic Gardens, full accountability for a commercial quality program. More recently, my work has extended into the systems and standards side of quality — a GLIMS qualification program at Bausch + Lomb, an ISO IDMP regulatory-data implementation for Takeda, and my current role supporting monograph and reference-standard development at the United States Pharmacopeia.

That combination — hands-on analytical method expertise, quality-system ownership, and structured project management (I hold the PMP and PMI Agile Certified Practitioner credentials and am a PMI member) — is what I bring to consulting engagements. Along the way I've also interacted directly with the FDA on submission responses and inspection matters, and responded to FDA Form 483 observations and deficiency letters — an understanding of quality problems from the bench to the boardroom, and from the lab floor to the inspector's desk.