Albert Rios

Lead approximately 14 engineers supporting 26 commercial manufacturing lines, with accountability for process engineering, technical troubleshooting, investigations, validation, reliability, continuous improvement, and technical ownership. Provide CDMO-side technical leadership for pharmaceutical customers, partnering with Quality, Regulatory, Supply Chain, Manufacturing, equipment suppliers, and

Led sponsor-side technical and quality oversight of CDMO operations across clinical and commercial manufacturing networks, supporting GMP compliance, regulatory alignment, technical performance, vendor accountability, and supply continuity. Directed end-to-end technology transfers from internal manufacturing to external CMOs, including batch-record readiness, equipment/facility fit, process-risk a

Worked within Quality Assurance providing sponsor-side oversight of CMOs and led transfers of commercialized products from internal manufacturing to external partners. Reviewed external-partner GMP documentation, deviations, change controls, process-performance data, validation/readiness evidence, and technical risks across CRO/CMO partnerships, integrating Quality requirements with manufacturing

Led engineering teams in a player-coach role while driving technical execution, troubleshooting, process characterization, validation, continuous improvement, and development of junior engineers. Served as Engineering Lead for major capital systems including a $20M plasma bottle-processing line and $10M bag-processing / material-handling system, managing URS/specifications, vendors, design executi

Served as technical SME supporting sterile Drug Product manufacturing and aseptic fill-finish across vials, prefilled syringes, cartridges, lyophilization, filling, stoppering, capping, isolator equipment, and associated manufacturing systems. Managed CMO partners and led MSAT / technology-transfer activities across internal and external Drug Product manufacturing networks, including batch-record

Led manufacturing engineering and process development for Class III implantable neuromodulation devices, supporting design transfer, design controls, DHF documentation, engineering changes, verification/validation, and production readiness. Partnered with R&D, Quality, Regulatory Affairs, Operations, and MRB on DFMEA/PFMEA, nonconformance investigations, root-cause analysis, CAPA, and compliant pr

Supported development, commercialization, and lifecycle activities for combination products and drug-delivery systems including autoinjectors, prefilled syringes, vial-adapter systems, needle-protection systems, primary-container interfaces, functional testing, and product-performance characterization. Served as lead sustaining engineer for complaint investigations and root-cause analysis, applyin

M.S. in Mechanical Engineering from California State University, Los Angeles.

B.S. in Mechanical Engineering from San Jose State University.