Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Process Science Associate - Technical Support

  • Jul 2022 - Aug 2023

  • Provided on the floor support during commercial manufacturing (MFG) and validation campaigns. • Executed protocol-driven large-scale studies and analysed the associated data. • Assisted in troubleshooting activities associated to the manufacturing process throughout cell culture and purification activities. • Provided training to MFG for the execution of PS owned documentation in the production area. • Managed MFG support trackers, performed scientific investigation. • Served… Show more • Provided on the floor support during commercial manufacturing (MFG) and validation campaigns. • Executed protocol-driven large-scale studies and analysed the associated data. • Assisted in troubleshooting activities associated to the manufacturing process throughout cell culture and purification activities. • Provided training to MFG for the execution of PS owned documentation in the production area. • Managed MFG support trackers, performed scientific investigation. • Served as Subject Matter expert (SME) for sampling and coordinated samples from MFG for QC and PS lab analysis. • Presented findings at group and occasionally interdepartmental meetings. • Managed MFG support trackers, performed scientific investigations. • Served as Subject Matter expert for Manufacturing support activities

• Biotech Production Specialist

  • Aug 2020 - Jul 2022

  - Included all aspects of biotech production activities related to upstream cell culture/media - Perform in-process sampling, Quality Control Chemistry and Quality Control Microbiology. Sample submission through LIMS. - GMP Champion on shift responsible for maintaining the highest quality standards on the floor, point of contact for any QA queries related to manufacturing process, provide communication guidance on issues arising from audits and how we can continuously improve… Show more - Included all aspects of biotech production activities related to upstream cell culture/media - Perform in-process sampling, Quality Control Chemistry and Quality Control Microbiology. Sample submission through LIMS. - GMP Champion on shift responsible for maintaining the highest quality standards on the floor, point of contact for any QA queries related to manufacturing process, provide communication guidance on issues arising from audits and how we can continuously improve operations. - Participated in Validation activities (Changeover protocols for >1 month), documenting swabbing of equipment parts following product changeovers as well as visually inspecting function of the equipment (outlining any out of norm discrepancies) - Worked alongside compliance/QA department for over 4 months presenting NOEs via ProcessCompliance, where I gained valuable experience when dealing with on-floor deviations, evaluating risk level and closing events within set timelines. - Assist with training of new employees (Aseptic behaviour/techniques and gowning training)



Mylan

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Cleanroom operator

  • Nov 2018 - Aug 2019

  County Galway, Ireland • As a cleanroom operator, I gained valuable experience performing environmental monitoring of classified Grade A, B and C areas of the cleanroom. Some of my roles are outlined below. • Followed the relevant gowning procedures (SOPs) when carrying out cleanroom duties. • My primary role involved performing interventions on the vial and syringe production lines. - lubricating the pumps with WFI at regular intervals, removing jammed caps/bungs aseptically during the production… Show more • As a cleanroom operator, I gained valuable experience performing environmental monitoring of classified Grade A, B and C areas of the cleanroom. Some of my roles are outlined below. • Followed the relevant gowning procedures (SOPs) when carrying out cleanroom duties. • My primary role involved performing interventions on the vial and syringe production lines. - lubricating the pumps with WFI at regular intervals, removing jammed caps/bungs aseptically during the production cycle. - Strict adherence to cGMP was essential, as well as compliance with the required quality systems and health and safety standards - Completing production batch records, logbooks in accordance with cGMP standards/written procedures Show less



Dunnes Stores

• Ireland
• Retail
• 700 & Above Employee

• Cashier

  • Sep 2016 - Feb 2017

  Handle cash transactions with customers using cash registers Scan goods and collect payments Issue receipts, refunds, change or tickets



Dew Drop Inn

• United States
• Hospitality
• 1 - 100 Employee

• Bartender

  • May 2015 - Aug 2016

  • Working in a high-pressure demanding environment • Interacting with customers, taking orders and serving drinks • Restock and replenish bar inventory and supplies