CEO/ OPERATIONS HEAD
 

Steven is the founder and serves as the CEO/ Operations Head of Pharmaceutical Technical

Solutions, Inc. (PTSI). He provides technical oversight and client representative support to the

Biotechnology, Gene Therapy, Cell Therapy, T-Cell, CAR T, Viral Vector, mRNA, Vaccine, and

Medical Device Industries. He leverages his biopharma experience in providing his clients with

innovative solutions to their complex problems.

He supports multiple Cell/ Gene Therapy, Viral Vector, and Biotech MFG Facilities from Detail

Design, Construction, MFG Operational Readiness, CQV, PAI Readiness, and licensure. He

leads his team in providing Biopharma Client Liaison, Engineering, Manufacturing, Process

Development, Tech Transfer, Quality, QC, and Reliability Centered Maintenance technical

consulting services.

Steven held various senior management positions at Amgen including Director of Facilities &

Engineering reporting to the Executive Vice President. He led a large commercial manufacturing

operations team of over three hundred representing manufacturing, engineering, operations,

quality, validation, and facilities. He has significant first-hand experience in successful EU/ QP

Auditor certifications, FDA Audits, and PAI inspection readiness and remediation for his team/

clients.

Led the Facilities and Engineering team in a $2.5B project at the Amgen Puerto Rico Site where

they drove the Design, Build, and CQV of several facilities in 2.5 years. Facilities included

Commercial Drug Substance, Drug Product, Fill/ Finish, QC Labs PD Lab, GMP Warehouse,

CUP, Admin, and Wastewater Treatment Plant.

Led the Parsons Construction Team (22 staff) with over 400 union workers in the construction of

BMS Large-Scale Biotechnology Manufacturing Facility (450,000 SF/ $900M) Greenfield Site in

Devens MA. Leveraged my organizational skills in leading the project back on schedule by

establishing a detailed, prioritized construction schedule, weekly performance metric, and

communication strategy with the overall team

As the Chief Manufacturing Officer of Pfenex, a Biosimilar company, he was responsible for the

Manufacturing, Quality, Engineering, and Process Development global functions for the

corporation. He established and executed the MFG Supply Chain strategy that supported the

launch of the company's pipeline of clinical/ commercial products.