Alan Johnson Email & Phone Number

Cambridge, Cambridgeshire, Gb

Business Process Owner for the Quality Risk Program at AstraZeneca. Lead a network that pro-actively identifies and mitigates Quality risks, to ensure and defend that all GxP Processes / Systems across the organization are successfully able to meet their Quality, Compliance and Reliability goals within the End to End product lifecycle.Integration of Quality Risk into all business and Quality processes to drive continuous improvement in Quality, Compliance and Reliability of these processes and systems.

Cambridge, Cambridgeshire, Gb

Relocated to Amgen Rhode Island to lead the Cleaning Validation program at the site and be Process Owner Validation. Pretty dynamic job as the Amgen pipeline is really starting to flow!!

Thousand Oaks, Ca, Us

Manage Qualification of the major elements of the ongoing multi-billion dollar capital investment program at Amgens Puerto Rico Facility. Strategies, Planning, Technical Support, Risk Assessments, Qualtiy Oversight, Workstream Guidance for Integrated Commissioning, Engineering and Automation Teams.Develop and Support Subject Matter Expert Program.

Management of companies projects, including, bidding, planning, resourcing, cost control, technical support, quality oversight, staff training. Main projects:Technical and Quality Management of $400M Mammalian cell based process facility. Zero observations during Pre-Approval Inspection. Partnered with company to help implement risk based validation approach. Earned preferential validation vendor status. Directed Validation Team for Gum-base dosing Facility ProjectIntegrated Puerto Rico facility systems, operation, and alliance into Pharmaplan worldwide consulting group

This role was requested by Pharmacia Global Technical Services Group.Direct Validation teams on Pharmacia’s Biotech projects in Sweden. Retrofit of Pre-filled Syringe facility. (Syringe containing Dry Lyophilized product + WFI chamber in ready to inject syringe)Retrofit of Growth Hormone manufacturing facility, Syringe line and packaging facilityValidation support services for new multi-product dual chamber syringe facilityDeveloped Validation Strategies and concepts for planned Biotech expansion program - including new multi-product manufacturing facility.Introduced key concepts of risk based qualification, and streamlined documentation & integrated commissioning processes.

Founding partner and Technical & Quality Manager of this start-up company. Project and Technical Management for $200M solid dosage center of excellence (Janssen). Directed Validation Team for $150M lyophilization and sterile fill facility validation (Pharmacia).Directed Validation Team for $130M sterile facility expansion (Wyeth) Directed Validation Resources for Medical Device, Solid Dosage, Computer Systems, Network and Infrastructure Projects, Clean Utilities, Creams and Sterile Facility Projects. Grew company from 10 person firm to multi-million dollar operation with over 100 staff.Training and Staff development.Secured exclusive validation vendor agreement with Pharmacia.

A brief hiatus from industrial projects to manage my families dairy farm interests in New Zealand. All aspects of farm operation and management including - milking, herd genetic development & health programs, feed management, Infrastructure development and maintenance.

Consultant engineer for various processing projects including:Project Manager Milk processing facility expansion. HTST, Aseptic Fill Lines, Cheese Manufacture - Industria Lechera (Puerto Rico).Ion Exchange Processing - CONVA (Spain)Juice Processing Facilities - Deprovesa (Spain) and Jahncke (Germany)Formulation & Bottling Line Project – Coca Cola (England)Waste Conversion and process line optimization Project -TriValley Growers (USA)Process Consulting / Quality Improvement Project – Chico-Thai (Thailand)Environmental Consulting - Sanofi Bio-Industries (Puerto Rico)

Technical management position responsible for installing, commissioning and then managing the operation of a new manufacturing line at the companies Puerto Rico facility. Part of the corporate team responsible to re-design, retrofit and manage an acquired manufacturing facility located in Washington State.

Programming, installation and commissioning, of the companies ion exchange equipment. Preparation of Technical Manuals and responsible for Client Training & Technical support.

Production Manager supervising 40 staff at the companies process facility in Hastings New Zealand.Managed a technical team responsible for quality and technical support at all the companies Processing Plants (4), Investigation of new process technologies including: Ion exchange, reverse osmosis, ultra-filtration, diffusion extraction and aseptic packing.