Excellence From Concept To Completion

Management Team

Our management team have collectively over 70 years experience working in the various industries within the Life Sciences industry including Pharmaceutical, Biopharmaceutical and Medical Devices. Expertise have been comprised in Project and Program Management, Regulatory Guidance and Compliance, Chemical and Biological Processes, Best Engineering Practices, Commissioning and Validation, Business Continuity and Quality Services.

 

John Devlin

John Devlin - CEO KPC International

 

 

 

 

 

 

John earned his degree in Chemical Engineering from University College Dublin and then spent the early part of his career in South Africa responsible for process optimization and troubleshooting new projects in bulk chemical manufacturing. Following these experiences John held roles of increasing levels of responsibility within the PM Group; projects included site selection and front-end design of a Greenfield Vial Filling Facility.

He then spent many years providing expert knowledge on Commissioning, Qualification & Validation to biotech companies such as Novartis, Gedeon Richter, Wyeth, Merck Serono & BMS, both nationally and internationally. He is an internationally recognized expert in the area of Commissioning and Qualification, John has been published in Pharmaceutical Engineering, May/June edition 2007 – “Integration of Commissioning and Qualification with other Phases of the Project Life Cycle”. John is well versed in latest industry guidelines including ASTM E2500.

In 2001 John established KPC International, with a view to providing specialist expert consulting services (Project Management/Plant Start-up) to clients in the Pharma/Biopharma industry. John has considerable experience in the strategic aspects of plant startup with particular emphasis on the assembly and management of Scope Definition, Master Plans, Execution Strategies, Execution Teams, Budgets and Schedules. In the past 8 years, John has been called into 4 bulk biotech projects all of which were experiencing problems. His task was to restructure and reorganize all aspects of the project execution so that each could be completed on time. His philosophy is to align all stakeholders on a common approach to start up, get the procedures and policies in place and then EXECUTE. John has vast experience in mobilizing teams for project execution and has a strong track record in delivering projects on time and within budget.
He has over 26 years’ experience in Pharma/Biopharma industries and is MBA qualified.

 

Julianne Hogan

Julianne Hogan - Senior Consultant KPC International

Julianne has over 17+ years’ experience in the biotech/biopharma startup industry. Building on her 1st Class Hons. Degree in Industrial Biochemistry, she spent 3 yrs conducting cell biology & molecular research with EiRx Therapeutics Ltd., where she also attained a Masters in Biotechnology.

Julianne then transitioned to Quality in Wyeth, establishing Quality Virology and Cell Biology laboratories and analytical methods to support a start-up biotech product. During this time she also led the Emergency Response Team, establishing biosafety procedures and health and safety risk assessments.

Following these experiences she moved to the Technology Transfer side of the business holding leadership roles in the introduction of vaccine manufacturing processes to Wyeth for clinical trial, process validation and commercial manufacture. In 2008 she also held a leadership role for the introduction of a new biotech product to Pfizer which involved; Designing and construction of a new manufacturing suite, Late stage development, Tech transfer of a new process, Operational readiness, Cleaning validation and Management of the stage gating process to manufacture materials for clinical trials.

For over the last 4 years she has provided consultation to many start-up biotech companies in Europe, United States and Canada tech transfer, new product introduction, project management, strategies and stage gating primarily as well as qualification of equipment, cleaning validation, etc. She has a wealth of knowledge on the manufacture of clinical trial, commercial material and Process Validation. She has extensive experience in Quality Risk Management; she holds a Diploma in Project Management from the Institute of Project Management and is a certified Lead Auditor for ISO 9001.