Open to opportunities

James O'Dwyer

@jamesodwyer

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Quality-focused bioprocess systems lead transitioning into Quality Assurance specialist.

Spain

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What I'm looking for

I seek a Quality Assurance role where I apply GMP/GDP expertise, data integrity oversight, and cross-functional project coordination to drive compliance and continuous improvement.

I am an organized, detail-driven bioprocess and documentation professional with hands-on experience in pharmaceutical manufacturing and upstream cell culture systems for biologics such as Enbrel-HC, Trastuzumab, Rituximab, and Somatrogon.

I have led data and documentation management using SAP, AMPS, LIMS and Veeva Vault, coordinated cross-functional projects (Continuous Improvement, Safety, CI & Safety Project Leadership), and ensured GMP/GDP compliance and audit readiness across manufacturing campaigns.

Currently preparing for PMP certification (exam scheduled early 2026) and seeking to transition into a dedicated Quality Assurance Specialist role where I can apply my manufacturing quality review, data integrity, and project coordination experience to support regulatory compliance and process optimization.

Experience

Work history, roles, and key accomplishments

Bioprocess System Lead

Pfizer

Oct 2022 - Sep 2025 (2 years 11 months)

Led upstream cell culture data and documentation for multiple biologic manufacturing campaigns, ensuring GMP/GDP compliance and batch readiness while driving continuous improvement and safety initiatives that supported timely batch release.

SAP AMPS LIMS Data Integrity Root Cause Analysis Project Coordination

Education

Degrees, certifications, and relevant coursework

Maynooth University

Bachelor of Science, Pharmaceutical and Biomedical Chemistry

2018 - 2022

Completed a Bachelor of Science in Pharmaceutical and Biomedical Chemistry with coursework and practical experience relevant to regulated biomanufacturing and laboratory environments.