Experience

Amicus Therapeutics

• United States
• Biotechnology Research
• 300 - 400 Employee

• Manufacturing Manager

  • Oct 2020 - Present

• Senior Manufacturing Process Specialist

  • Apr 2019 - Oct 2020

  Scale up and tech transfer of new and existing manufacturing processes.Creation, review and approval of process validation plans, protocols and reports. Design of validation studies and execution of such.Deviation investigation and root cause analysis, effective CAPA creation and implementation.Documentation of internal and external change controls.MBR Optimization.Planning, management of multiple projects and communication of progress to management.Collaboration and communication with CMO’s as an SME to support on-going manufacturing campaigns for biologics, gene therapy and small molecule API manufacturing.Development and review of new and existing SOPs and protocols.Continuous analysis of process data and preparation of reports. Presentation of data and findings to executive team. Show less



Janssen Sciences Ireland UC

• Ringaskiddy, Cork

• Manufacturing Process Specialist

  • Feb 2015 - Mar 2019

  Manufacturing Process Specialist for Equipment Preparation area and Buffer Preparation area. Responsible for identifying, resolving non-conformances in both areas and documenting investigations and root cause analysis on the Trackwise system. Responsible for implementing corrective and preventative actions in these areas. Involved in a number of projects while MPS for these areas, including installation of the new washer in equipment preparation, installation of the new CIP skid. Provided training for manufacturing technicians along with regular training on improvements to the processes of both areas Shift Manufacturing Process Specialist for the Purification business unit. Responsible for dealing with non-conformances and documenting the investigations into these on the Trackwise system, Carrying out active gram evaluations at each step in the process to ensure the process was proceeding in a typical manner, Dealing with supplier complaint investigations and closing out such, Providing on the floor support and troubleshooting for manufacturing technicians on equipment equipment such as skids, columns, vessels along with control systems such as Unicorn, Delta V and MES (Electronic batch Records). Presented in a number of audits. Shift Manufacturing Process Specialist for the Clinical and Small Scale Commercial business unit. Responsible for the successful introduction of two new products to site. This involved regular conference calls with colleagues in the US to effectively transfer the new product to site along with cross functional collaboration with QA, MES, Automation, Engineering and PDMS. This role also involved regular review and approval of specification documents. Providing on the floor support and troubleshooting for technicians. Show less



Design Pro

• County Limerick, Ireland

• Technical Writer

  • Oct 2014 - Feb 2015

  Responsible for creating instruction manuals for use of the equipment which they manufactured, Creating spare parts lists, Improving the quality and simplicity of the instruction manuals. This is a precision automation company which produces robotic arms capable of functioning on multiple planes, 3-D printed parts, New renewable energy technologies Responsible for creating instruction manuals for use of the equipment which they manufactured, Creating spare parts lists, Improving the quality and simplicity of the instruction manuals. This is a precision automation company which produces robotic arms capable of functioning on multiple planes, 3-D printed parts, New renewable energy technologies



Teagasc

• Athenry, Co Galway

• QC Analyst

  • Mar 2012 - Sep 2012

  Worked in a Genomics laboratory where I was responsible for the completion of a project which involved the extraction of mud snail DNA and subsequent PCR and gel electrophoresis. The goal of the project was to optimize the amount of DNA that I could extract from the snail. i successfully trialed a new method of extraction using Chelex beads and implemented this as part of their SOPs. I was responsible for the tracking of lab inventory and ordering new reagents and equipment as they were required. I also assisted a PHD student with a project on reproductive health of dairy cows which involved sample collection, sample transportation and sample storage. I also assisted in the RNA analysis of the samples using an Agilent Bioanalyzer. Show less