Summary
Overview
Work history
Education
Skills
Timeline
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Kate Tobin

Limerick

Summary

Organized and dependable candidate successful at managing multiple priorities within a fast paced environment. Sound knowledge of biotechnology production and experienced in new product and line introduction with an emphasis on good manufacturing practices and good documentation practices. Successful in problem-solving and critical thinking in times of stress.

Overview

4
4
years of professional experience
4
4
years of post-secondary education

Work history

Upstream Manufacturing Coordinator

Regeneron
Limerick, Limerick
02.2023 - Current
  • Coordinate cross functional team meetings to correct and prevent issues affecting manufacturing operations.
  • Author protocols and oversee product changeover activities and new product introduction activities into process areas.
  • Coordinate introduction and validation of new equipment, liaise with QA Validation for continuing validation of vessels, lines and equipment.
  • Prepare for internal and external audits by performing walk downs of production areas to ensure documentation and procedures are adhered to as per associated SOP's.
  • Coordinate and schedule tasks between multiple functional groups such as maintenance, calibrations, automation, QC and IT without impacting production.


Biotech Production Specialist

Regeneron
, Limerick
08.2020 - 02.2023
  • Carried out day-to-day production operations, working efficiently and productively with all team members.
  • Adhering to all GMP and GDP at all times when carrying out tasks and recording data.
  • Adhering to a process-driven schedule and adapting to a rapidly changing environment.
  • Reviewing completed batch records for GDP using ALCOA+ principles.
  • Documented deviations in the ProcessCompliance system and assessed the risks or deviations.
  • Completed secondments within the compliance department to meet deviation closure deadlines.
  • Assisted in CAPA implementation on the floor.
  • Experience interacting with auditors from multiple bodies, for example, FDA, HPRA, partner audits etc.
  • Performed regular in-process tests and yield calculations, ensuring production met predefined quality targets as per manufacturing records.
  • Consistently followed company EHS standards, maintaining secure, low-risk working environments.
  • Identified equipment malfunctions, arranging prompt repair to maintain production.

QC/QA Technician

Johnson and Johnson
Limerick
09.2019 - 08.2020
  • Tested products for various parameters to ensure they adhered to quality standards.
  • Used LIMS to document test results and defects in real time.
  • Reported defect issues for swift remedy, eliminating operational disruptions.
  • Performed write ups as per good documentation practices.

Education

Bachelor of Science - Pharmaceutical and Forensic Sciences

Limerick Institute of Technology
Limerick
09.2015 - 09.2019

Skills


Strong organisation and time management skills, very adaptive to fast paced environment


Great communication and interpersonal skills, experience dealing with conflict and conflict resolution


Excellent understanding of GMP, GDP and ALCOA practices


Experienced within cross functional team meetings to assist decision making


Self motivated with a proactive problem solving mindset

Timeline

Upstream Manufacturing Coordinator

Regeneron
02.2023 - Current

Biotech Production Specialist

Regeneron
08.2020 - 02.2023

QC/QA Technician

Johnson and Johnson
09.2019 - 08.2020

Bachelor of Science - Pharmaceutical and Forensic Sciences

Limerick Institute of Technology
09.2015 - 09.2019

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Kate Tobin