Global Vaccine Center - Team
Matthew Pino - Project Executive
Founder / President : M3 BIOPHARMA INC 2013-current Provides expertise with Manufacturing, Quality Operations and Supply Chain to support ongoing supply at manufacturing, packaging and distribution vendors. • Led Technology Transfer of Clinical and Commercial Drug Products to external contract organizations (CDMO/ CMO), provided Technical Writing of SOPs, batch records, and validation documents. • Generated GAP Analysis and implementation strategy for the Supply Chain and Distribution aspects for ERP systems. • Supported Quality Systems assessment and implementation regarding vendor approval and management, Person-InThe-Plant services, Supplier Qualification including program development, compliance audits and Quality Systems development and remediation. • Provided services regarding CMC generation, Regulatory documents and Strategy. • Performed QA Audits and Gap Analysis/ Risk Mitigation strategies.
Director of Manufacturing: NextMed USA, Inc. 2012-2013 Administered risk assessment, cost analysis and contract negotiations to support ongoing supply at the contract manufacturing, packaging and distribution vendors. • Managed the development of supply chain models, contributed to corporate partnering and business development efforts for the global supply chain operations; including US and EU Drug Product Distribution. • Oversaw the Supply Chain aspects of new ERP system and provided project management support for implementation efforts. • Supported Quality Systems implementation regarding vendor approval, management, and Regulatory filings.
Sr. Director of Manufacturing and Environmental, Health & Safety: Suneva Medical, Inc. 2010-2011 Oversaw multiple functional areas (Production, Supply Chain Management, and EH&S), including budgetary responsibility and representative of the leadership team for the Company in FDA approved and ISO certified facility. • Managed vendor relations and in conjunction with QA, sourced and ensured appropriate qualification of suppliers for existing and new components related to Operations. • Analyzed new production technologies; provided recommendations of potential changes, identified issues for development, and implemented capacity improvement and yield improvement for existing manufacturing and supply chain functions.
Vice President – CDMO: Symyx Technologies, Inc. 2009 Spearheaded the CDMO (Contract Development and Manufacturing Organization) Business Unit; including Formulations Development, CGMP Operations Teams and Sales & Marketing. • Prepared budget and business strategy for 3-5 year growth of formulations and manufacturing contract services BU. • Managed BU Sales/BD Group regarding contract negotiations, pricing and revenue forecasts which lead to doubling top line revenue. • Supported overall relationships between customer and facility.
Manager, Manufacturing Operations: Biogen Idec Inc. 2002-2004 Actively participated in operational start-up activities of Biogen Idec’s new large-scale manufacturing facility (NIMO): Coordinated Mfg staffing plan, personnel transfers, start-up budget, and Operations Project Team. • Served as Project Lead for Corporate Quality System Improvement Team relating to Product Change Over in a Continuous Manufacturing environment. • Worked with Corporate Quality Systems Improvement Teams relating to: Lot/Part Numbering, Unified Deviation and CAPA system, and Phase Appropriate Technology Transfer. • Coordinated Manufacturing Department roles in the design, construction, validation (equipment IQ/OQ/PQ), process start up, and commercial manufacturing for a new bulk antibody formulation production suite using disposable technology. • Developed and supervised Bulk Processing Area (BPA) group regarding production scheduling, materials planning, and coordination of the technology transfer of products into BPA.
Manufacturing Operations Manager: Regeneron Pharmaceuticals, Inc. 1996-1998 Managed a $35+ million capital project including technology transfer, manufacturing and successful Regulatory Approval of PRP intermediate for Merck & Co., Inc.’s PedvaxHib® conjugate vaccine. • Assisted Project Team in writing all Standard Operating Procedures and Manufacturing Batch Records required for Process Demonstration start. • Coordinated and reviewed information for the CMC sections of the ELA/ PLA submission package • Directly responsible for budgeting, hiring, evaluations/HR aspects of the PRP Production Group, including Fermentation, Purification and Washroom Support Groups. • Reviewed and approved Validation IQ/OQ/PQ/PV protocols, and managed the Manufacturing.
Manufacturing Associate: Regeneron Pharmaceuticals, Inc. 1994-1996 Initiated the start-up and operation of a 3000 L and 700 L fermentor, ultra-centrifuges, and various ultra-filtration modules involving a 10X scale up. • Supervised fermentor modifications/ change control, preventative maintenance program, and CIP skid design, implementation for 700 L fermentor and purchased 2000 L and 200 L cell culture bioreactor for Pilot Plant use • Assisted in the setup of recombinant protein Master Cell Bank and Master Working Cell Bank. • Cross-trained in Purification group, performed experiments concerning derivatization and refolding of recombinant protein.