Steven Sandoval

About Steven Sandoval

Steven founded and serves as the President/ CEO of PTSI Pharmaceutical Technical…

Experience

1. CEO Operations Head

   Ptsi - Pharmaceutical Technical Solutions, Inc

   Jan 2010 — Present

   Steven founded Pharmaceutical Technical Solutions, Inc.(PTSI) and has served as the CEO/ Head of Operations since 2010. He has been providing technical oversight and client liaison support to the Biotechnology, Gene Therapy, Cell Therapy, T-Cell, CAR T, Vaccine, and Medical Device industries for over 30 years. Steven and his PTSI team have supported multiple Cell Therapy MFG Facilities from Detail Design, Build, MFG Operational Readiness, CQV, PAI Readiness, and Licensure. He continues to lead his team in providing Biopharmaceutical Engineering, Manufacturing, and Quality/ QC Technical Consulting Services. He has overseen the establishment of Commissioning/ Validation Master Plans and implementation, and provided leadership during successful FDA/ Regulatory PAI, Biennial, QP Certification, and Inspection Readiness/ Remediation Execution for his clients. Steven held various senior management positions at Amgen including Director of Engineering/ Facilities reporting to the Executive Vice President. He has significant first-hand experience preparing for, and interfacing with, the FDA and other global regulatory agencies during pre-licensure and biennial inspections of commercial cGMP biopharmaceutical manufacturing facilities. Steven served as the Chief Manufacturing Officer of Pfenex, a Biosimilar company. He was responsible for Manufacturing, Quality, Engineering, and Process Development Global Functions for the corporation. He established a Manufacturing Supply Chain Strategy to support the company\'s budgeting and resource planning as well as operations programs/ vision to internal and external stakeholders. Steven led in the selection and management of Operations Biopharmaceutical Contract Service Providers (CMO’s/ CRO’s). He served as the primary technical liaison and subject-matter-expert to the organization as well as U.S. and international agencies.

Skills

• Continuous Improvement
• Operations Management
• Process Improvement
• Contract Management
• Process Engineering
• Engineering
• Quality System
• Start-Ups
• Fda
• Compliance
• Problem Solving
• Quality Systems
• Technical Writing
• Reliability Centered Maintenance
• Cgmp
• Pharmaceutical Industry
• Troubleshooting
• Leadership
• Quality Management
• Gmp
• Team Leadership
• Pharmaceuticals
• Capa
• Root Cause Analysis
• Facilities Management
• Change Management
• Risk Management
• Automation
• Biotechnology
• Biopharmaceuticals
• Scheduling
• Supervisory Skills
• Program Management
• Documentation
• Team Building
• Hvac
• Lean Manufacturing
• Cross-Functional Team Leadership
• Project Planning
• Planning