Steven Sandoval Sr.

Strategic Leadership & Executive Management:

Founded and leads Pharmaceutical Technical Solutions, Inc. (PTSI) a biopharma client representative company, serving as CEO/ Operations Head since 2010.
Provides strategic direction, operational leadership, and organizational oversight across complex biopharmaceutical programs.
Serves on the Board of Directors of Gemini Bio and Scientific Advisory Board of Abzena, contributing biopharma expert guidance on growth, innovation, and operational excellence.

Biopharma Manufacturing & Technical Operations:

Extensive leadership in Biopharma, Biotech, Gene Therapy, Radiopharma, Viral Vector, Cell Therapy, CAR T, mRNA, Vaccine, and 503a/ 503b Compounding
Direct end-to-end support for manufacturing sites, including Detail Design, Construction, MFG Operational Readiness, CQV, PAI readiness, and FDA/ EU Licensure
Led large-scale biopharma operations teams, including a 300-member cross-functional team at Amgen

Regulatory Compliance & Inspection Readiness:

Deep experience with FDA audits, EU/ QP Certifications, PAI Inspection Readiness, and regulatory remediation for both internal teams and client operations
Ensures compliance through QA, QC, CQV, GMP Tech Writing, and Deviation/ CAPA oversight

Program & Project Leadership:

Directed a $2.5B site expansion project at Amgen Puerto Rico, overseeing Design, Build, and CQV of multiple GMP facilities within 2.5 years
Led construction of a 450,000 square foot, $900M BMS large-scale biotech manufacturing facility in Devens, MA, managing 22 professional staff and over 400 union trades.
Specializes in bringing complex capital, manufacturing, and technology transfer projects back on schedule through structured planning, performance metrics, and stakeholder communication

Supply Chain, Tech Transfer, & Commercial Readiness:

Developed and executed global manufacturing supply chain strategy as Chief Manufacturing Officer at Pfenex, supporting clinical and commercial product launches
Provides expertise in process development, tech transfer, and commercial readiness across multiple product modalities in partnership with our qualified CDMOs

Engineering, Reliability & Facilities Management:

Led Facilities & Engineering organizations across multiple sites, including reliability-centered maintenance programs, utilities operations, and GMP facility management.
Oversaw engineering operations supporting drug substance, drug product, fill/ finish, utilities, warehouses, QC laboratories, and wastewater systems

Cross-Functional Technical Consulting:

Guides teams, delivering expertise in biopharma, engineering, manufacturing, process development, QA, QC, reliability centered maintenance/ CMMS, CQV, and client liaison functions
Provides technical oversight and solutions for complex operational, engineering, and regulatory challenges across the biopharmaceutical sector