Jonathan Matthews, PhD, PMP
Project Director at HOYA Surgical Optics- Claim this Profile
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Bio
Lucius Rossano
Jonathan was the project manager in the Manufacturing Operations group at BMS for a new product introduced from R&D in New Brunswick,NJ into manufacturing at Swords, Dublin. As the project R&D leader I worked closely with Jonathan to execute the tech transfer and validation of the synthesis. Through his tireless work habits, attention to detail, and keen insight, Jonathan ensured the success of this work. He contributed to the thought process of this first ever Quality by Design filing for a BMS drug substance, carefully considering the guidance provided by the FDA and EMEA health authorities and determining how that would translate into a manufacturing process. He established a powerful network to ensure that all issues were addressed in the most useful manner. Jonathan was a very talented chemist and an effective leader. Thanks to Jonathan, this work was a tremendous success. After validation of the synthesis we then proceeded to oversee the writing of the EMEA filing document. Here Jonathan demonstrated his skills of collaboration and communication and he ensured that the manufacturing description document was well aligned with the process development work. Again his work was excellent. In summary, Jonathan is an outstanding colleague who performs all aspects of his work in exemplary fashion.
Piotr Malysa
Jonathan is a very energetic person and leader. He was the product champion of the very first Active Pharmaceutical Ingredient I worked on in The BMS Company. He was also my 'buddy'. In other words he was responsible for my introduction to work in the company. Thanks to Jonathan's help I assimilated quickly and could work effectively. I would like to recommend Jonathan for a Team Lead or Specialist position.
Lucius Rossano
Jonathan was the project manager in the Manufacturing Operations group at BMS for a new product introduced from R&D in New Brunswick,NJ into manufacturing at Swords, Dublin. As the project R&D leader I worked closely with Jonathan to execute the tech transfer and validation of the synthesis. Through his tireless work habits, attention to detail, and keen insight, Jonathan ensured the success of this work. He contributed to the thought process of this first ever Quality by Design filing for a BMS drug substance, carefully considering the guidance provided by the FDA and EMEA health authorities and determining how that would translate into a manufacturing process. He established a powerful network to ensure that all issues were addressed in the most useful manner. Jonathan was a very talented chemist and an effective leader. Thanks to Jonathan, this work was a tremendous success. After validation of the synthesis we then proceeded to oversee the writing of the EMEA filing document. Here Jonathan demonstrated his skills of collaboration and communication and he ensured that the manufacturing description document was well aligned with the process development work. Again his work was excellent. In summary, Jonathan is an outstanding colleague who performs all aspects of his work in exemplary fashion.
Piotr Malysa
Jonathan is a very energetic person and leader. He was the product champion of the very first Active Pharmaceutical Ingredient I worked on in The BMS Company. He was also my 'buddy'. In other words he was responsible for my introduction to work in the company. Thanks to Jonathan's help I assimilated quickly and could work effectively. I would like to recommend Jonathan for a Team Lead or Specialist position.
Lucius Rossano
Jonathan was the project manager in the Manufacturing Operations group at BMS for a new product introduced from R&D in New Brunswick,NJ into manufacturing at Swords, Dublin. As the project R&D leader I worked closely with Jonathan to execute the tech transfer and validation of the synthesis. Through his tireless work habits, attention to detail, and keen insight, Jonathan ensured the success of this work. He contributed to the thought process of this first ever Quality by Design filing for a BMS drug substance, carefully considering the guidance provided by the FDA and EMEA health authorities and determining how that would translate into a manufacturing process. He established a powerful network to ensure that all issues were addressed in the most useful manner. Jonathan was a very talented chemist and an effective leader. Thanks to Jonathan, this work was a tremendous success. After validation of the synthesis we then proceeded to oversee the writing of the EMEA filing document. Here Jonathan demonstrated his skills of collaboration and communication and he ensured that the manufacturing description document was well aligned with the process development work. Again his work was excellent. In summary, Jonathan is an outstanding colleague who performs all aspects of his work in exemplary fashion.
Piotr Malysa
Jonathan is a very energetic person and leader. He was the product champion of the very first Active Pharmaceutical Ingredient I worked on in The BMS Company. He was also my 'buddy'. In other words he was responsible for my introduction to work in the company. Thanks to Jonathan's help I assimilated quickly and could work effectively. I would like to recommend Jonathan for a Team Lead or Specialist position.
Lucius Rossano
Jonathan was the project manager in the Manufacturing Operations group at BMS for a new product introduced from R&D in New Brunswick,NJ into manufacturing at Swords, Dublin. As the project R&D leader I worked closely with Jonathan to execute the tech transfer and validation of the synthesis. Through his tireless work habits, attention to detail, and keen insight, Jonathan ensured the success of this work. He contributed to the thought process of this first ever Quality by Design filing for a BMS drug substance, carefully considering the guidance provided by the FDA and EMEA health authorities and determining how that would translate into a manufacturing process. He established a powerful network to ensure that all issues were addressed in the most useful manner. Jonathan was a very talented chemist and an effective leader. Thanks to Jonathan, this work was a tremendous success. After validation of the synthesis we then proceeded to oversee the writing of the EMEA filing document. Here Jonathan demonstrated his skills of collaboration and communication and he ensured that the manufacturing description document was well aligned with the process development work. Again his work was excellent. In summary, Jonathan is an outstanding colleague who performs all aspects of his work in exemplary fashion.
Piotr Malysa
Jonathan is a very energetic person and leader. He was the product champion of the very first Active Pharmaceutical Ingredient I worked on in The BMS Company. He was also my 'buddy'. In other words he was responsible for my introduction to work in the company. Thanks to Jonathan's help I assimilated quickly and could work effectively. I would like to recommend Jonathan for a Team Lead or Specialist position.
Credentials
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Introduction to Blockchain Technologies
CourseraSep, 2020- Nov, 2024 -
Technical Risk Assessment Facilitator Level 1
GSKMar, 2017- Nov, 2024 -
Project Management Professional (PMP)
Project Management InstituteNov, 2022- Nov, 2024
Experience
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HOYA Surgical Optics
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Singapore
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Medical Equipment Manufacturing
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200 - 300 Employee
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Project Director
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Jan 2018 - Present
● Leading diverse cross-functional project teams (R&D, Operations, Design Assurance, QA, Regulatory, Clinical, Marketing, Supply Chain, IP) to develop and commercialise new intraocular lens (IOL) and IOL inserter products.● ESG committee team member● Coach teams through planning, design, development, verification, validation, clinical evaluation, regulatory submission and design transfer to operations in multiple global regions including EU MDR, US FDA.● Accountable for the overall strategy, timeline, budget, scope and resourcing of two essential, high priority ongoing projects.● Led the completion of a new and improved IOL inserter project from target to first regulatory approvals in 2020.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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NPI Technical Manager
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Sep 2013 - Dec 2017
● Coached multiple R&D API chemistry teams in the US and UK to develop manufacturing processes under QbD for commercialisation for the NPI Centre of Excellence.● Led a cross-functional team of 10 chemists and engineers across manufacturing and R&D to revamp a tool for process Manufacturability Assessment with successful roll out and embedding in the work of 100+ R&D chemists. Recognised as a manufacturability SME. Gold level appreciation award achieved.● Engaged in 5 to 6 complex projects concurrently on an ongoing basis. Example products were cabotegravir (Cabenuva) and tafenoquine (Krintafel).● Led supply chain strategy and procurement decisions routinely.● Accountable in primary technical operations for process validation at an external CDMO, including leading technical risk assessments, root cause analyses and CAPA generation.● In early years the role was entitled Project Leader in the API New Product Introduction Centre of Excellence (NPI CoE).
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Process Development Scientist
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Mar 2011 - Aug 2013
● Project leader for new product introduction tech transfers between manufacturing sites in Pfizer and participated in Hazops.● Technical operations for cGMP manufacturing, engaged actively in process innovation, continuous improvement, operations support, troubleshooting and root cause analysis for the Organic Synthesis Plant in Singapore ● Project leader for new product introduction tech transfers between manufacturing sites in Pfizer and participated in Hazops.● Technical operations for cGMP manufacturing, engaged actively in process innovation, continuous improvement, operations support, troubleshooting and root cause analysis for the Organic Synthesis Plant in Singapore
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Bristol Myers Squibb
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Manufacturing Technology Chemist
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Jul 2005 - Apr 2010
● Lead roles in the MT Chemistry Department, working with engineering in technology transfers from R&D.● Process scale-up, validation, manufacturing support and filing of new API processes. A key example was apixaban (Eliquis).● Valuable experience in QbD and in working in a cGMP environment.● Authored the drug substance manufacturing description for the apixaban dossier, which was developed under QbD. ● Secondment to support a sister manufacturing site in Barceloneta, Puerto Rico for three months in 2007.
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University College Dublin
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Ireland
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Higher Education
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700 & Above Employee
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Postdoctoral
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May 2005 - Jul 2005
● Development of monodentate phenanthroline-derived ligands for asymmetric catalysis.● Successfully developed the synthesis for the framework of the ligands prior to taking up my position in BMS. ● Development of monodentate phenanthroline-derived ligands for asymmetric catalysis.● Successfully developed the synthesis for the framework of the ligands prior to taking up my position in BMS.
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Education
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1999 - 2004
University College Dublin
Ph.D., Synthetic Organic Chemistry -
1994 - 1999
University College Dublin
BSc. (Hons.), Chemistry -
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High School Dublin
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High School Dublin
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