Cian Gibbons Email & Phone Number

County Kerry, Ireland

Ireland

Digital Transformation Project Management - Implementation and customization of Lean software in the Life Science Technology sector, working both onsite and in a remote capacity with a leading French multinational pharmaceutical company, as well as a world renowned US academic medical centre.

Galway, Ireland

• Responsible for the study of the chemical and physical interaction between living tissue and the materials used in medical devices, and the biological response to said interactions.• Coordination of biocompatibility testing required by all major regulatory bodies as per International Standard ISO 10993.• Completion of Biocompatibility Assessments and Report documents as per SOP.• Working as part of a cross functional team of scientists, engineers, regulatory affairs in order to… Show more • Responsible for the study of the chemical and physical interaction between living tissue and the materials used in medical devices, and the biological response to said interactions.• Coordination of biocompatibility testing required by all major regulatory bodies as per International Standard ISO 10993.• Completion of Biocompatibility Assessments and Report documents as per SOP.• Working as part of a cross functional team of scientists, engineers, regulatory affairs in order to determine device classification, material characterization, material equivalency, rationales for testing.• Development of biological and chemical test protocols.• Coordination of the logistics associated with test article acquisition, preparation and transfer of samples to the appropriate internal/external contract laboratory (WuXi AppTec, NAMSA) for testing.• Test Report Review.• Investigation of unexpected events/test results e.g. protocol acceptance criteria not met, adverse biological response – completion of FIR (Failure Investigation Report) if applicable.• Toxicology – Completion and review of CSA (Chemical Safety Assessment) – A toxicological risk assessment carried out on new materials or new material uses based on chemical composition, potential leachables/degradation, history of safe use, route/duration of exposure.• Technical Document Writer/Approver (Windchill database)- PCAF, DCAF, SCIA/VCAF, Technical Report, NCEP/CAPA, Biocompatibility Assessment Report (BCA-R).• Cross-site representation – Biocompatibility Scientist representative for project teams based at Boston Scientific’s Cork site as well as Galway, periodic site visits to Cork for team meetings/project updates.• Experience in New Product Acquisition – assessment of site move, gap analysis and transfer of biocompatibility documentation into the Boston Scientific Quality System.• Lean Six Sigma Yellow Belt training – Problem Solving for Practioners. Show less

Westport, Mayo, Ireland

• Environmental monitoring of Botox classified areas, Grade A-D, ISO 5/6/7/8. Batch monitoring at set-up, compounding, transfer, filling and capping stages of product, both in open-RABS and closed RABS/RTP systems.• Aseptic biopharmaceutical drug manufacturing processes – component preparation (siliconization, autoclaving, depyrogenation) sterile filtration, filling, lyophilization/freeze drying, capping.• Bioburden analysis of Allergan’s Biologics 1 and 2 water systems – sampling +… Show more • Environmental monitoring of Botox classified areas, Grade A-D, ISO 5/6/7/8. Batch monitoring at set-up, compounding, transfer, filling and capping stages of product, both in open-RABS and closed RABS/RTP systems.• Aseptic biopharmaceutical drug manufacturing processes – component preparation (siliconization, autoclaving, depyrogenation) sterile filtration, filling, lyophilization/freeze drying, capping.• Bioburden analysis of Allergan’s Biologics 1 and 2 water systems – sampling + testing.• Control technical document author, reviewer, approver – Standard Operating Procedures, Document Change Requests, Validation Protocols, Validation Reports, Work Instructions.• Trackwise QMS author – Routine/Non Routine Change Controls, CAPA, Non-conformance, LIR.• Aseptic process validation experience – cleanroom, isolator/filling machine, lyophilizer, depyrogenation tunnel, parts washer, RTP canisters, LIMS hardware – label printers, mobile PCs, scanners.• Design of LIMS environmental monitoring programmes for the classified areas of Allergan Westport’s Biologics 2 facility.• Validation of closed-RABS Grade A isolator system – Baseline/At Rest/Media Fill/Process Development/PPQ batch environmental monitoring, writing of validation protocol and reports.• FMS administrator – daily review of alarm reports, reporting issues, troubleshooting, vendor liaison.• Experience working with Bausch & Stroebel, Franz Ziel, Fedegari, Steritech, IMA, ATEC, FMS systems.• Daily/weekly Microbiology department representation at APEX Tier 1/2/3 meetings.• Weekly participation in Biologics R+D QA meetings.• Risk Assessment facilitator, reviewer, approver.• Experience and involvement in FDA, HPRA audits.• Microbiology OpEx representative, implementation of OpEx at Allergan’s Biologics 2 facility.• Experience with quality testing methods and interpretation of results, review and approval of lab documentation.• Endotoxin, media growth promotion, microbial identification. Show less

Honours Bachelor Of Science (B.Sc. Hons), Biotechnology & French, 2:1

Subjects Studied: Biochemistry, Chemistry, Microbiology, Botany, Zoology, Pharmacology, Bioinformatics, Statistics, Computer science.

Level 8 Postgraduate Higher Diploma, Computer Science - Software Development, 1:1

Subjects Studied: Object Orientated and Agile Software Development (Java), Computer Architecture and Technology Convergence, Database.