Experience

Magnostics

• Ireland
• Biotechnology Research
• 1 - 100 Employee

• Regulatory and Quality specialist

  • Dec 2020 - Present



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior QC Chemist

  • Aug 2017 - Dec 2020

  To perform tests and analysis on raw materials (i.e. API and excipients). • Adhere to cGLP when performing In House, US and EU pharmacopeia testing protocols. • Performing peer review on tests, analysis and documentation. • Writing, keeping track of and updating Investigations, laboratory documents, Testing standards and SOP’s. • Identifying continuous improvement opportunities in the laboratory and participating in continuous improvement projects for the Laboratory • Ensuring assigned 5S area is maintained in a constant state of IMEX compliance and audit readiness; Certify correct labelling of glassware, ensuring assigned zone is suitably stocked and that all logbooks and documentation in the area is reviewed and in date. • In charge of IMEX Issues tower and Financials; Making sure each issue addressed on the issues tower is appropriately resolved or escalated. As well as trending how, said issues and their resolution affect the lab’s overall schedule adherence and cycle time. • Involved in transferring Eliquis methods into Raw materials lab, working closely with both Pfizer and BMS team to troubleshoot when necessary, test method robustness and ensure the success of the project. •Training Champion for shift, ensuring that the team have the required training completed and working with outside vendors to deliver training. • Monitors and orders laboratory consumables; Trained in using SAP & Ariba purchasing system. Liaising with external vendors in the purchasing, installation and qualification of equipment. • Regularly participates in internal laboratory audits, to ensure process is kept to a high cGMP standard. •Proven capability of responding readily to internal and external queries. Show less



Battelle

• United States
• Research Services
• 700 & Above Employee

• Senior Research Assistant

  • Nov 2015 - Aug 2017

  To actively participate in all the steps of production development including the pre-formulation, formulation, product and process development, scale-up and support for the field trial or transfer to pilot plant. My main responsibilities as a formulator include: • Preparation of standards for Validation and Calibration of Analytical instruments • Sample logging • Carrying out Bioformulation such as; Feasibility studies, Amendment selection and screening, Formulation optimization, Encapsulation techniques, On-seed testing, Storage stability testing • Conduct in-process testing of formulations to determine if the product meets all requirements • Based on the test results, determine whether the product requires any adjustments and if so compute/ gauge the amount of inputs to be increased/decreased to adjust the formulation to satisfy parameters • Prepare a sample batch by following the required manufacturing steps • Calculate the quantities of the required ingredients to adjust the entire batch and communicate the “adjustment” requirements to supervisor/customer • Adhere to cGLP and CIPAC/ASTM testing protocols • Compile and provide summaries and reports of stability and testing data • Communicate effectively and collaborate with other departments (i.e. Analytical team, Regulatory team) within the organization to plan, execute, evaluate and report on new product development projects. • Writing and updating SOPs, providing in process and Health and Safety training to new and existing staff when required Show less



Teagasc

• Ireland
• Research Services
• 700 & Above Employee

• Laboratory Assistant

  • Jul 2014 - Dec 2014

  To examine key aromatic compounds in food (i.e. Cheese, milk, meat etc.) and beverages, also to develop and validate testing methods. My main responsibilities as an analyst in the flavour chemistry laboratory include: • Preparation of standards • Sample logging (sample receipt, analysis route) • Preparation of client samples • Operation of advanced gas chromatographic methods involving extraction, concentration, separation and identification of volatiles compounds by different head space gas chromatographic techniques. Show less



Next

• United Kingdom
• Retail
• 700 & Above Employee

• Sales Assistant

  • Sep 2013 - Apr 2014