Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Manager QC Technical Resources

  • Jan 2023 - Present

  Raheen, Limerick

• Sr. QC Scientist

  • Feb 2021 - Jan 2023

  Raheen, Limerick



MSD

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technical Specialist

  • Sep 2018 - Feb 2021

  Brinny, Cork • Coordinated and led Analytical Method Validation and Technical Transfers; strategy document, protocol and report writing, study design, new test procedures, analyst training. • Led and participated in cross-functional problem-solving teams for troubleshooting and investigations, providing technical support, guidance and expertise and demonstrating strong problem solving and experimental design skills as well as critical evaluation of data. • Optimisation of Bioassay and ELISA… Show more • Coordinated and led Analytical Method Validation and Technical Transfers; strategy document, protocol and report writing, study design, new test procedures, analyst training. • Led and participated in cross-functional problem-solving teams for troubleshooting and investigations, providing technical support, guidance and expertise and demonstrating strong problem solving and experimental design skills as well as critical evaluation of data. • Optimisation of Bioassay and ELISA methods including development of investigational protocols and execution of troubleshooting laboratory experiments. • Daily, weekly and monthly data management through routine assay performance scorecard generation, data trending/statistical analysis, and provision of hyper care during investigations and times of poor assay performance. • Authoring of regulatory submission updates including audit mapping of information through coordination and collaboration with cross-functional team. • Participated in divisional and external audits. • Mentored and Coached new hires within the team, developing their technical ability and essential knowledge required for their role. • Experienced in change control process required for implementation of new methods, method updates and regulatory submissions. • Performance Qualification of new equipment including preparation and review of SDLC documents ensuring accuracy, reliability, consistent intended performance and continuity of commercial testing. • SharePoint administrator, flexibility in configuration and governance enables team collaboration and knowledge management. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Analyst

  • May 2017 - Sep 2018

  Research Area: QC Analyst in the Immunology and Cell Culture (ICC) department, specialising in Virology, Mycoplasma and PCR. Achievements: • Project managed the introduction of new biosimilars into to mycoplasma and virology labs and contract testing of virus and residual DNA samples adhering to project timelines. • Validation of new biosimilars: protocol and report writing, scheduling and execution of testing. • Coordinated virology and DNA testing of new products by CRO’s… Show more Research Area: QC Analyst in the Immunology and Cell Culture (ICC) department, specialising in Virology, Mycoplasma and PCR. Achievements: • Project managed the introduction of new biosimilars into to mycoplasma and virology labs and contract testing of virus and residual DNA samples adhering to project timelines. • Validation of new biosimilars: protocol and report writing, scheduling and execution of testing. • Coordinated virology and DNA testing of new products by CRO’s including review of validation protocols and acceptance criteria, raising PO’s, design of sampling plans, sample management, reporting of results. • Scheduled in vivo testing of drug product, stability and syringe transformation project batches including POR preparation, coordination of mice for in vivo assay and reporting of results for batch disposition. • Performed routine and non-routine testing of in-process and release samples using cell culture, microbial and real time PCR assays. • Continuous Improvement (CI) Champion: led weekly CI meeting, organised and chaired priority project meetings leading to an 80% reduction in deviations. • Pfizer Human Performance practitioner for investigations caused by human error including conduction of interviews, composition of reports and creation of CAPA’s. • Audit preparation with focus on GMP and Data Integrity compliance. • Six Sigma yellow belt trained. Show less



University College Cork

• Ireland
• Higher Education
• 700 & Above Employee

• PhD Biochemistry

  • 2011 - 2016

  Research Area: Hypothesis and discovery based research using a molecular biology and cell based assay approach to investigate translational bypassing in Escherichia coli and Streptomyces coelicolor. Discovered first example of ribosomal bypassing in the bacteria Streptomyces coelicolor, novel frameshifting candidates in bacteria and archaeal domains. Responsibilities: Execution of research goals, publications, establishing collaborators and develop technical skill set



Self-Employed

• Piano Teacher

  • 2005 - 2016

  Responsibilities: Pupils include 10 children and one adult, involves class preparation for each individual child and preparation of students for the Royal Irish Academy of Music exams in piano.



Biochemistry Dept. UCC

• Demonstrator

  • Sep 2010 - Mar 2014

  Responsibilities: Training, development and mentoring of undergraduate biochemistry student groups, demonstrating biochemical techniques and instructing students in lab report writing, responsible for grading students’ practical continuous assessment.



Recode Lab, UCC

• Laboratory Technician

  • Jun 2010 - Sep 2010

  Searched for new slippery motifs involved in Transcriptional Slippage.



Farm Relief Agency

• Farm Manager

  • 2005 - 2009

  Responsibilities: Day to day management of farm during summer.