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Steven Sandoval Sr.


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 leverage 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 Labs, GMP Warehouse, CUP, Admin, and Wastewater Treatment Plant.

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.

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