Summary
Overview
Work History
Education
Skills
Timeline
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Liam Curoe

Boston,MA

Summary

Determined and well-rounded individual with more than 7 years working as Scientist within the Biopharma industry across various cGMP environments, start-ups, and established organizations. Sharp and focused professional skills in quality control, platform development and regulatory management.

Overview

7
7
years of professional experience

Work History

Sr. Scientist, CMC Stability

QurAlis
11.2023 - Current
  • Drafted IND/IMPD submissions and updates for FDA and EMA regulatory filings
  • Oversaw and managed multiple external vendors (CMO, CRO, CDMOs) regarding API manufacture, DP Formulation and Stability studies.
  • Managed and built-out laboratory for Oligonucleotide manufacturing, processing, formulation and analytics.
  • Implemented QMS and EDMS system for laboratory activities, QA compliance, audit trails and regulatory compliance.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
  • Performed method development and optimization on LC-MS, UHPLC platforms for external transfer and validation.

QC Development Scientist

Integrated DNA Technologies
01.2022 - 09.2023
  • Conducted experiments in laboratory environment for product development purposes.
  • Documented changes during experiments, noting unexpected issues arising during research activities.
  • Authored documents related to new processes implemented, SOPs.
  • Managed USP method transfers, new method development and validation.
  • Performed complex troubleshooting and assisted in leading initiatives to solve challenging problems with assays and instrumentation.
  • Performed IQ/OQ/PQ testing on various QC instrumentation, including LC-MS, HPLC, CE.
  • Led interdepartmental teams in launching new projects, including cost tracking, RCA, and countermeasure implementation.
  • Managed timelines on multiple NPD projects for various projects.
  • Developed analytical methods of UPLC, RP, IEX, CE, and ddPCR instrumentation.
  • Designed and maintained new QMS/QCMR to integrate with current LIMS system to capture assay results.

Synthesis Production Scientist

Integrated DNA Technologies
08.2020 - 01.2022
  • Collaborated with team members to achieve targets for on-time delivery.
  • Oversaw synthesis and purification of oligonucleotides by HPLC, AKTA platforms.
  • Assisted in designing, developing and refining solid support platforms for oligonucleotide synthesis.
  • Authored documents for new SOPs, reviewed and oversaw new procedure development and batch record generation.
  • Designed and implemented 5S changes to laboratories to streamline production and improve efficiency.
  • Designed and maintained upstream and downstream processing protocols.
  • Captured all tasks and data generated for product in LIMS and ELN system.
  • Handled failure troubleshooting, preventative and breakdown maintenance of instrumentation.
  • Maintained detailed records of all manufacturing information for cGMP batch records.
  • Planned laboratory experiments to confirm feasibility of processes and techniques to produce modifications with special characteristics.

Lead Analyst

Procter & Gamble Co
06.2018 - 06.2020
  • Led a team of 5 lab analysts on my shift to ensure high-throughput of submitted samples.
  • Prepared and validated buffers and in-house reagents, calibrators and controls in advance of laboratory testing and analysis orders.
  • Prepared and examined specimens using variety of instruments, histologic and molecular diagnostic techniques.
  • Analyzed clinical samples on LC/MS-MS, resolving unusual data trends and handling chromatography and instrument alarms as appropriate.
  • Engaged in instrument maintenance and basic troubleshooting of LC-MS/MS, HPLC, TOC, Endotoxin, serving as primary operator of instrumentation and reviewing QC and calibrator performance for assay integrity.
  • Set and oversaw quality assurance guidelines for laboratory work.
  • Ensured all data collected was verified in LIMS system and physical lab notebook records.
  • Authored documents and SOPs for processes owned within the laboratory. Ensured compliance therein with QA/RA for data integrity and governance.

Education

Bachelor of Science - Molecular Biology

University of Iowa
Iowa City, IA
05.2018

Skills

  • Technical Writing, IND/IMPD Filing
  • Project Management
  • Method Development
  • Process Optimization
  • Oligonucleotide Synthesis/Processing
  • ISO 9001, 13485
  • Data analytics, (JMP, SAS)

Timeline

Sr. Scientist, CMC Stability

QurAlis
11.2023 - Current

QC Development Scientist

Integrated DNA Technologies
01.2022 - 09.2023

Synthesis Production Scientist

Integrated DNA Technologies
08.2020 - 01.2022

Lead Analyst

Procter & Gamble Co
06.2018 - 06.2020

Bachelor of Science - Molecular Biology

University of Iowa

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