16+ Years | GMP Manufacturing & Technical Leadership

Experience Across the Manufacturing Lifecycle

Process engineering and Technical Operations experience across regulated pharmaceutical and medical-device manufacturing. The common thread: understand the manufacturing problem, structure the technical work, and connect the people needed to move it forward.

Broader Leadership, Grounded in Technical Execution

A concise view of experience. The resume is the complete record.

DEC 2023 – OCT 2026 / OTSUKA PHARMACEUTICAL

Associate Director, Process Engineering

Led a team of 3 senior engineers across placebo tablet manufacturing, drug product packaging, and stability-related manufacturing. Directed capital projects from equipment selection through qualification and GMP production readiness, oversaw engineers managing CMOs for critical raw materials, and partnered with Manufacturing and Quality to resolve deviations, execute qualifications and validations, and maintain operational readiness.

MAY 2021 – DEC 2023 / OTSUKA PHARMACEUTICAL

Senior Staff Process Engineer

Led process engineering, validation, and continuous improvement for an ingestible sensor and tablets, and took ownership of the newly formed Process Engineering group. Revitalized the stability program and developed the framework to reestablish the site’s process monitoring program for SPC.

APR 2018 – MAY 2021 / GRIFOLS DIAGNOSTIC SOLUTIONS

Senior Engineer, MSAT

Led the site-wide Continued Process Verification program for commercial recombinant proteins. Expanded CPV to a new manufacturing site, developed dashboards and a data management system, and authored and executed PPQ protocols for antigens transferred to a new facility.

JUN 2015 – MAR 2018 / INTARCIA THERAPEUTICS

Manufacturing / Process Engineer III

Supported aseptic GMP operations through process improvements, validation activities, and technical investigations. Led implementation of a glove integrity testing program and introduced environmental-monitoring equipment into GMP manufacturing, including qualification.

JUN 2010 – JUN 2015 / NOVARTIS PHARMACEUTICALS

Process Development Engineer

Supported drug product process development, technology transfer, scale-up, and introduction of new products into GMP manufacturing. Developed and scaled capsule-filling processes for spray-dried APIs and executed process and cleaning validations for product changeovers.

How I Approach Technical Leadership

  1. Understand the technical problem.
  2. Connect the dependencies and make them visible.
  3. Identify and prioritize risks.
  4. Align expertise around the work.
  5. Drive execution toward a clear outcome.
The thinking behind these principles