Steven Sandoval

Scientific Advisory Board Member

Steven Sandoval is the founder and serves as the CEO/ Operations Head of Pharmaceutical Technical Solutions, Inc. (PTSI). Providing technical oversight and client representative support to the Biotechnology, Gene Therapy, Viral Vector, Cell Therapy, T-CELL, CAR T, mRNA, 503a/ 503b Compounding, and Vaccine Pharmaceutical Industries since 2010. He leverages his biopharma experience in providing his clients with innovative solutions to their complex problems.

He continues to support Pharmaceutical MFG Facilities from Detail Design, Construction, MFG Operational Readiness, CQV, PAI Readiness, and FDA/ EU 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 during his 20 years that included Director of Facilities & Engineering Operations 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.

Steven led the Facilities and Engineering team in a $2.5B project at the Amgen Puerto Rico Site where they drove the Design, Construction, MFG Operational Readiness, CQV, PAI, and FDA/ EU licensure of several facilities in 2.5 years. Facilities included Commercial Drug Substance, Drug Product, Packaging/ Labeling QC Labs PD Lab, GMP Warehouse, Central Utility Plants, Administration, and Wastewater Treatment Plant.

Steven also 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 Biopharma Supply Chain strategy that supported the launch of the company’s pipeline of clinical and commercial products.