Patrick Begley Email & Phone Number

San Jose, California, United States

As the President & Principal Consultant, I specialize in biologic product development, CMO manufacturing, and regulatory registration for patient-centric combination products. I am well known for my expertise in managing technical transfers, clinical manufacturing, and process validation for aseptic operations. As an industry expert, I provide business development consulting for suppliers and service providers, enhancing marketing strategies, operations, and product offerings to meet the… Show more As the President & Principal Consultant, I specialize in biologic product development, CMO manufacturing, and regulatory registration for patient-centric combination products. I am well known for my expertise in managing technical transfers, clinical manufacturing, and process validation for aseptic operations. As an industry expert, I provide business development consulting for suppliers and service providers, enhancing marketing strategies, operations, and product offerings to meet the evolving demands of the pharmaceutical industry. Additionally, I support CDMO selection and CMC development, ensuring compatibility, stability, and compliance. Show less

(Remote)

In this role, I was recognized for leading the successful launch of Novavax's first authorized drug product, establishing global manufacturing and supply chain operations across 9 sites, and validating over 500M doses. I managed global technical transfers, oversaw $300M in procurement contracts, and ensured 100% on-time delivery of materials. I authored and enhanced technical transfer and QMS policies, ensuring consistent quality and process control across global sites, while overseeing… Show more In this role, I was recognized for leading the successful launch of Novavax's first authorized drug product, establishing global manufacturing and supply chain operations across 9 sites, and validating over 500M doses. I managed global technical transfers, oversaw $300M in procurement contracts, and ensured 100% on-time delivery of materials. I authored and enhanced technical transfer and QMS policies, ensuring consistent quality and process control across global sites, while overseeing COVID-19 vaccine prefilled syringe development, regulatory compliance, and staff training, ultimately reducing CAPEX and accelerating vaccine development. As a leader, I delivered clinical supply for a pivotal Phase III trial with 29K+ subjects, meeting all primary endpoints. Additionally, I aligned global S&OP demand plans, managing over $250M in contractual obligations and coordinating raw material supply for worldwide manufacturing. Show less

Hayward, Ca

At Intarcia, I managed procurement and strategic sourcing for over 150 suppliers, overseeing $125M in annual spend. I developed supplier performance metrics, leading to a 15% reduction in high-risk suppliers and $3M in savings. Additionally, I served as Interim Head of QA, resolving over 30 overdue deviations and a $15M API crisis, and successfully completed development and design transfer of a HCP UX tested and approved surgical procedure kit for device implantation, achieving commercial… Show more At Intarcia, I managed procurement and strategic sourcing for over 150 suppliers, overseeing $125M in annual spend. I developed supplier performance metrics, leading to a 15% reduction in high-risk suppliers and $3M in savings. Additionally, I served as Interim Head of QA, resolving over 30 overdue deviations and a $15M API crisis, and successfully completed development and design transfer of a HCP UX tested and approved surgical procedure kit for device implantation, achieving commercial manufacturing readiness in <12 months and significantly reducing COGs. Show less

Redwood City, California, United States

As the director of Drug Product Manufacturing, I led external manufacturing operations for clinical development and commercial manufacturing readiness of a pipeline of six biosimilar assets with different investment partners. I significantly contributed to the FDA approval and successful commercial launch of UDENCYA (pegfilgrastim-cbqv) PFS and AI, CIMERLI (ranibizumab-eqrn), and YUSIMRY (adalimumab-aqvh) AI. Throughout this tenure, I solved complex protein stability issues by inventing a… Show more As the director of Drug Product Manufacturing, I led external manufacturing operations for clinical development and commercial manufacturing readiness of a pipeline of six biosimilar assets with different investment partners. I significantly contributed to the FDA approval and successful commercial launch of UDENCYA (pegfilgrastim-cbqv) PFS and AI, CIMERLI (ranibizumab-eqrn), and YUSIMRY (adalimumab-aqvh) AI. Throughout this tenure, I solved complex protein stability issues by inventing a novel DP formulation and filling process, installed custom robotic isolator aseptic manufacturing equipment and managed CAPEX investments for manufacturing, device assembly, packaging and QC testing, enabling cGMP stability and successful R&D development for all pipeline combination product assets. Show less

Franklin Lakes, Nj

* Managed Global Quality and Technical Support Organization for 18 yrs (12 reports), Servicing >250 Global Accounts, and Supporting +13 BD product lines.* Commercial Marketing/Sales Strategy & Innovative Business Case Development * BD Consulting Services - B2B Business Providing Hands-On Support for Customer Success* SME for Glass/Plastic Prefilled Syringe, Autoinjectors, Pens, and other Drug-Delivery Devices* Quality, Technical, Regulatory and Manufacturing Support for… Show more * Managed Global Quality and Technical Support Organization for 18 yrs (12 reports), Servicing >250 Global Accounts, and Supporting +13 BD product lines.* Commercial Marketing/Sales Strategy & Innovative Business Case Development * BD Consulting Services - B2B Business Providing Hands-On Support for Customer Success* SME for Glass/Plastic Prefilled Syringe, Autoinjectors, Pens, and other Drug-Delivery Devices* Quality, Technical, Regulatory and Manufacturing Support for Product Lines* Manufacturing Consulting Services: *Supply Chain Value Stream Mapping *Defect Root-Cause Investigations, *Aseptic Process Troubleshooting, *OEE, and Quality Improvement Audits following Lean, Six Sigma, Kaizen, TQM, 6S, and Gemba methodologies, tools and industry best practices. Show less

Franklin Lakes, Nj

During my tenure with Becton Dickinson, I managed global R&D support for over 250 customer sites, driving over $1B in sales and achieving 11% YOY growth for 12 consecutive years. I served as a pharmaceutical manufacturing consultant for flu-vaccine and pandemic preparedness, doubling capacity and reducing COGs by 50%. As a biologic combination product SME, I supported the commercialization of over 100 vaccines and biologic drug products in various delivery devices.* Sales Technical… Show more During my tenure with Becton Dickinson, I managed global R&D support for over 250 customer sites, driving over $1B in sales and achieving 11% YOY growth for 12 consecutive years. I served as a pharmaceutical manufacturing consultant for flu-vaccine and pandemic preparedness, doubling capacity and reducing COGs by 50%. As a biologic combination product SME, I supported the commercialization of over 100 vaccines and biologic drug products in various delivery devices.* Sales Technical Support Manager +13 BD Product Lines* SME Consultant for Aseptic Manufacturing Operations and Device Assembly & Final Packaging. * Consultant/Project Leader for Lean, 6-Sigma Root Cause, Quality Improvement and OEE Audits * SME for Equipment Selection, Sourcing, FAT/SAT/IOQ/PQ/PPQ, and Capacity Increase Desing, Planning, and Implementation achieving >600/min and 1M units per batch.- Clinical Filling Equipment Manufacturing, Sales, Support, Field Service, Training Show less