Tyler Pegoraro

Engineer with 12+ years of experience in pharmaceutical development, spanning early R&D through Phase 3 clinical manufacturing. I thrive at the intersection of science, engineering, and operations—bringing complex drug products from concept to clinic.

Key highlights:

Led end-to-end development of a manufacturing platform for implantable drug products (from research to Phase 3 readiness)

Contributed to 3 INDs and authored 100+ quality and regulatory documents

Supported 15+ clinical manufacturing campaigns across inhaled, subcutaneous, and ophthalmic routes

Applied statistical modeling and design of experiments (DOE) to guide formulation and process optimization

Inventor on 2 patents related to ophthalmic drug products and delivery devices

I’m a data-driven problem solver who leads by example and values team success. Passionate about innovation, I enjoy uncovering the story behind each API and building drug products that truly serve patient needs.

Most recent role: Principal Engineer I (2023 - present) at Alcon

Led and executed two manufacturing campaigns for production of Phase 2 CTM. Developed process that incorporated manual and automated operations. Supported equipment design and qualification of automated delivery device loading robot. 
Key contributor to CMC activities. Led collaboration activities for multi-million-dollar partnership with excipient manufacturer. Led sterilization validation project for electron beam sterilization of DP at external vendor. Authored and reviewed IND sections. Led manufacturing investigations and executed corrective actions with effectiveness checks in alignment with QA. Organized and wrote the pFMEA report for the implant manufacturing process.
Planned and executed the formulation screening using novel excipients and a new API that hit initial target product profile specification. Generated plan for Phase 3 readiness that identified process gaps and executed process optimization activities.

University of Virginia, 2012 (B.S.)

Biomedical Engineering and Materials Science (Nanomedicine)