Stability Team Lead

• Jul 2022 - Present

Release and Stability Team Lead

• May 2019 - Oct 2022

Senior Scientist

• Nov 2018 - Mar 2019

I am based in Limerick in Ireland working on combination products for vision care. I am the Senior Scientist of the Chemistry laboratory, currently working on a new combination product nearing its commercial production. I am responsible for the upcoming audit preparation for multiple international audits, the data integrity strategy of all the quality labs (micro, metrology and chemistry), all compliance activities such as procedural updates and gap analysis, sampling and interval testing of our raw materials, method transfer and development, review/approval and investigations of the data produced in the chemistry laboratory, as well as qualification and maintenance of the equipment within the labs.

Analytical Scientist

• Oct 2016 - Oct 2018

I joined Indivior in October 2016 when they established their purpose-built facilities in 2017 which includes six non-GMP and GMP laboratories from Pre-Formulation to Analytical Development. My responsibilities during this role included:• Carried out routine analysis using HPLC, GC, Karl Fischer, pH, FTIR, dissolution, and disintegration, including the write up of data generated in GMP laboratory to a high standard with good communication to relevant departments and third parties• Method development, validation/verification (HPLC, UPLC, GC, LC-MS, QTOF, H2O content) in-line with the local and global procedures• SME for multiple pieces of equipment, documents and procedures for the MHRA inspections• Completed IQ/OQ/PQ/RQ for new equipment, followed by routine calibration and trouble-shooting when required• Supporting other departments such as Pre-Formulation, Formulation and Organic Chemistry with statistical analysis, Design of Experiments, method development and equipment training• Designing the method lifecycle process from development, forced degradation studies and validation as outlined in ICH Q12.• Using statistic skills to support cross functional documentation such as eCTD submissions using Minitab• Involved in creating the QMS for a new purpose-built laboratory including policies, SOPs, WI and ACDs.• Created compliance documents such as logbooks and paperwork packages• focusing on new techniques or technologies with a 'blue sky' approach as to keep up to date and create a laboratory with cutting edge technology.

Analytical Chemist

• Jul 2014 - Oct 2016

Responsible for ensuring all required formulation, feasibility work, analysis, validation, stability testing, industrial trials and technical file preparation are performed on time and to the required standards.Created and maintained stability protocols, generated data from stability studies and validation studies using Empower 3 and created reports such as extrapolating shelf life extensions using Mini Tab, bulk hold time, stability transfers etc.Carried out Stability Testing on Finish Product Health Care Products using HPLC, GC, Karl Fischer etc, as well as routine calibration and trouble shooting on equipment within the lab, carried out OOS/OOT investigations, raising Deviations on Track Wise including initiating and completing CAPA’sWrite up on data generated in GMP laboratory to a high standard with good communication to relevant departments and third partyDrafting Module Three Documents, such as internal Certificate of Analysis, 32P82, 32P81 and communicating with Local and Global Regulatory bodies as well as supply, procurement and the manufacture of finished products.

RSC Member

• 2014 - 2015

Member of the Royal Society of Chemistry since January 2014 Member of the Royal Society of Chemistry since January 2014

Pharmaceutical and Forensics Analysis

• Sep 2010 - May 2014

I have recently achieved a Second Class Honours degree in Pharmaceutical and Forensics Analysis (Level 8) at Limerick Institute of Technology and I will be graduating in October 2014 with a BSc. I have recently achieved a Second Class Honours degree in Pharmaceutical and Forensics Analysis (Level 8) at Limerick Institute of Technology and I will be graduating in October 2014 with a BSc.

Laboratory Technician

• Mar 2013 - Sep 2013

I worked in most departments in my seven months working with Biomnis Ireland including Biochemistry, Hematology, Microbiology and Autoimmunity / Allergy testing. I worked in most departments in my seven months working with Biomnis Ireland including Biochemistry, Hematology, Microbiology and Autoimmunity / Allergy testing.

Customer Care Agent

• Jun 2012 - Jan 2013

I worked with Arise both full time and part time from June 2012 to January 2013. My responsibilities at that time included ensuring customer support requests are resolved at the first point of contact, make speedy decisions, win customer trust quickly and show empathy through active listening, log customer information and achieve daily, weekly and monthly performance metrics. I worked with Arise both full time and part time from June 2012 to January 2013. My responsibilities at that time included ensuring customer support requests are resolved at the first point of contact, make speedy decisions, win customer trust quickly and show empathy through active listening, log customer information and achieve daily, weekly and monthly performance metrics.