Greater Dublin
“Knowledge is power”. This saying has always resonated with me. The fact that in this inconceivably complex world there will always be opportunities for learning and self-development; and that any piece of knowledge, however obscure, may be useful. It is this thirst for knowledge that has underpinned my career to date. When I started studying genetics I was fascinated that this biochemical rollercoaster track we call DNA inside each of our cells could dictate so much about who we are, from our physiology to our personality. That within this blueprint comprised of billions of letters, a single error - like that misspelling in a novel that detail-oriented individuals like myself would notice - could have monumental consequences. I was sympathetic to the fact that for many disease sufferers, often there was no treatment available due to the rarity of their condition. From my ambition to work at the forefront of scientific innovation and impact the lives of disease sufferers around the world, I arrived in the biopharmaceutical sector where I have been working in a research capacity for the past four years. Now, in my quest to expand my knowledge, I am keen to lend my skills to a new functional area such as quality assurance or regulatory affairs. I am an organised and invested team player, with excellent verbal and written skills which would benefit the cross-functional and external engagement required in these job areas. My attention to detail is also well known and I execute all tasks to the highest standard.
- Manage the implementation of regulatory restrictions to ensure the compliant supply of biological drug products to the appropriate markets. - Executed a project to support the continued and uninterrupted supply of product to Great Britain in response to Brexit. - Coordinate the assessment of global change controls requiring regulatory input. - Prepare regulatory reports in support of the Annual Product Quality Review process. - Notify CMOs of revisions to analytical testing documents together with the associated implementation strategies and regulatory considerations. - Coordinate the preparation of regulatory documents by CMOs in support of market filings.
- Manage the implementation of regulatory restrictions to ensure the compliant supply of biological drug products to the appropriate markets. - Executed a project to support the continued and uninterrupted supply of product to Great Britain in response to Brexit. - Coordinate the assessment of global change controls requiring regulatory input. - Prepare regulatory reports in support of the Annual Product Quality Review process. - Notify CMOs of revisions to analytical testing documents together with the associated implementation strategies and regulatory considerations. - Coordinate the preparation of regulatory documents by CMOs in support of market filings.
- Lead process optimisation and range-finding studies for mammalian (CHO) cell culture processes. - Implemented GxP document management system as part of a cross-functional team. - Excellent written ability as a result of drafting, reviewing and approving broad range of technical documents. - Liaised with vendors and service providers as representative of several key instruments and equipment. - Lead 5S project for freezer management and standardisation of sample collection, storage and disposal.
- Established electronic country folders to house regulatory documents received in relation to an acquired drug product, thereby improving access. - Supplied global affiliates with data relating to their region(s) for due diligence activities. - Introduced to standard regulatory processes such as use of the CTD format and the submission of variation requests.
- Ensured all public spaces including the lobby, courtyard and smoking area were maintained in a clean and presentable state. - Provided guests with information on the range of Irish brands stocked by the gift shop. - Multicultural workforce.
- Trained in the safe handling of incoming patient samples in accordance with SOP documents. - Dispatched samples to the relevant division for testing. - Received extensive training in Fluorescence In Situ Hybridization (FISH). - Responsible for preparing up to 25 patient slides each evening for analysis the following day. - Analysed samples from patients with suspected congenital abnormalities. - Identified rare genetic abnormality with respect to a particular patient, prompting further tests.