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Trish Melton

Trish Melton

 

Managing Director of MIME Solutions

 

Professional biography

Summary

  • Project Management (EPC, product launch/development, engineering & non engineering projects, PM Training and PM Publications)
  • Pharmaceutical Engineering, Validation & Compliance
  • Management Consultancy & Business Management/Improvement

 

Trish Melton

BSc (hons), PhD, MBA, CEng, CSci Fellow Institution of Chemical Engineers

Managing Director MIME Solutions Ltd

Trish launched MIME Solutions in November 2003 – her vision being to support companies through the identification & implementation of projects and business strategies.

Trish is a Chartered Chemical Engineer who has worked as a Project Manager & Project Management Consultant within both engineering & non-engineering Projects world-wide, predominantly within the Global Pharmaceutical Industry.

Trish has extensive experience of Project Management, Product Development, Change Management & also the regulatory needs of the Pharmaceutical Industry. She has worked as both a service provider & an end user and uses an innovative approach to the development of appropriate strategies, which considers both technical & business
needs whilst meeting Client requirements Trish is currently working within the ISPE Working Group updating the ISPE BPC Baseline Guide Trish is a member of the IChemE Council and the Membership Committee.

 

Relevant experience

  • 2003 to present – Director of an Engineering & Management Consultancy delivering project management, business change management, regulatory and GMP consultancy assignments for Clients in the Pharma, Chemicals & Healthcare Industries. Current Clients include Astrazeneca, GSK, Barts NHS Trust and ISPE.
  • 2002 to 2003 – Divisional Head of Atkins PharmaChem delivering project & consultancy services to the Pharma and Chemical Industries. Regulatory Consultancy assignments with key Pharma Clients, Set-up of the Validation & Compliance Department, Compliance Risk Reviews of “live” projects such as a £30M BioPharma Project, Operational Improvements across the division.
  • 2000 to 2002 – As a Project Consultant, development of the concept of a generic structured approach to Project Management in GSK through active involvement in non-engineering projects such as R&D Product Development (managing the regulatory lifecycle & compliance risk) & Corporate Facility Rationalisation & Relocation. Management of the implementation of “lean manufacturing”.
  • 1999 – 2000– Overview project management of a major new Primary Manufacturing Facility in the Asia Pacific Region – managing GMP issues. associated with multipurpose facilities. Overview project management of the conceptual design of a major new Secondary Manufacturing & Packaging Facility in India, developing the regulatory strategy
  • 1997 to 1999 - Manager of Projects - Overall responsibility for coordinating all projects across the company, including resource management, project performance monitoring, management of Client relationships & line management of the Project Managers, Project & Mechanical Engineering Departments.
  • 1997 to 1999 - Manager of QA & Validation - Management of the QA System (in line with ISO9000) which was flexible enough to cater for a varied Client base via use of Quality Plans, i.e. Project Specific Quality Manuals.
  • 1998 to 1999 - BPC Plant, Korea - Project Director & Validation Director leading the Client/Consultant Project Management & Validation Team that delivered the 1st plant in Korea to be designed, installed & commissioned to FDA Standards. During the project further support was provided to the Client in managing the regulatory & product development strategy. This work was in partnership with a major UK based pharma company & involved the development of a fast track strategy to take a new drug from clinical trial, through registration to launch.
  • 1995 – 1998 – Major Antibiotic Facility (Smithkline Beecham) – Primary Pharma Facility –Installation of new concentration, crystallisation, separation & drying plant as well as a new kegging system within a classified clean room – all validated to FDA standards, GMP Plant Upgrade & Antibiotic Facility Commissioning Support (GlaxoWellcome) plus various conceptual design consultancy assignments
  • 1991 to 1994 – Project Engineer/Manager & Validation Engineer for a £5 Million Human Hormone Facility. Scale-up of fermentation, purification (chromatography) & freeze drying process in compliance with MCA & FDA (Eli Lilly).
  • 1989 to 1991 – Chemical Engineering Lecturer at Edinburgh University

 

Selected Publications

Melton P M (July 2005) – 1st Book Published in a series – “Project Management Toolkit: Success at every Stage” (ISBN: 0-85295-484-0)

Melton P M (July 2005) – 7th World Congress in Chemical Engineering (& ChERD journal), “The Benefits of Lean Manufacturing: What Lean Thinking has to offer
the Process Industries”

Melton P M (April 2004), ISPE Seminar, Brussels, “Regulatory Risk Assessment”: the application of risk assessment principles to the determination of the level of GMP.