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Patrick Begley is listed as DP MS&T Leader | Principal Consultant for Biologic Combination Product Development | Global CMO/CDMO Management | CMC Regulatory Submissions | Quality, OEE and Operational Excellence at Combination Product Consulting, based in San Jose, California, United States. AeroLeads shows a matched LinkedIn profile for Patrick Begley.
Patrick Begley previously worked as President at Combination Product Consulting and Director, Drug Product Manufacturing at Novavax. Patrick Begley holds Bs, Mechanical Engineering And Minor In Biomedical Engineering from Drexel University.
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✅ Principal Consultant for Clinical Development of Tailored Platform, Biologic Combination Products from Concept to Commercialization, and Global External Manufacturing Leader Providing Remote and PIP Oversight of DP Operations from Formulation to Finished, Packaged, Labeled and Serialized Drug Product. ✅ Experienced Pharmaceutical Product Lifecycle Management Project Leader (Vial-2-PFS or PFS-2-AI/OBI Device), support supplier selection, procurement, CMO/equipment selection, manufacturing process development, and commercial packaging of patient-centric combination products, ensuring compliance with design control and global regulatory requirements.✅ Pandemic Vaccine Manufacturing SME - Led DP MS&T & Manufacturing leader for Ph III clinical supply, CMC/PD, Scale-up and Commercial launch of Novavax’s 1st authorized drug product, the "Novavax Covid-19 Vaccine, Adjuvanted" / A.K.A. Nuvaxovid ROW, Achieved Technical Transfer to +9 CMO and partner sites to establish over 500M doses of capacity in MDV, UDV and PFS and achieved authorization in over 40 countries. * This is one of 4 pandemic vaccine manufacturing capacity scale-up projects I have led over my career. ✅ Highly Skilled Procurement, Strategic Sourcing and Supplier Relationship/Performance Manager, with +25 years of experience supporting Pharmaceutical & Biologic Combination Product and Medical Device Manufacturing.✅ Highly Experienced Supplier Quality, Relationship Management and Performance Improvement SME, Highly experienced in Root Cause Investigations, CAPA's, and Driving Supplier Continuous Improvement Programs Resulting in Significant Cost Reductions throughout Supply-Chain Operations and Logistics.✅ ✅ External Manufacturing Operations leader, successfully developing three biosimilar assets concurrently which achieved FDA approval in vials, prefilled syringes and autoinjector devices.
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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.
(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.
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.
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.
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.
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.
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Patrick Begley works for Combination Product Consulting.
Patrick Begley is listed as DP MS&T Leader | Principal Consultant for Biologic Combination Product Development | Global CMO/CDMO Management | CMC Regulatory Submissions | Quality, OEE and Operational Excellence at Combination Product Consulting.
Patrick Begley is based in San Jose, California, United States while working with Combination Product Consulting.
Patrick Begley has worked for Combination Product Consulting, Novavax, Intarcia Therapeutics, Inc., Coherus Biosciences, and Becton Dickinson And Company.
You can use AeroLeads to view verified contact signals for Patrick Begley at Combination Product Consulting, including work email, phone, and LinkedIn data when available.
Patrick Begley holds Bs, Mechanical Engineering And Minor In Biomedical Engineering from Drexel University.
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