Scott O'Brien

· Ensure operational compliance with cGMP, GDP, and internal quality systems across aseptic manufacturing operations in support of timely product and material release.

· Provide on-the-floor quality support and real-time guidance during manufacturing escalations, deviations, and discrepancies to ensure adherence to regulatory standards.

· Review executed batch records, investigations, and protocols, ensuring resolution of all issues prior to product disposition.

· Collaborate with cross-functional teams including Manufacturing, Quality Control, and Document Control to maintain alignment on quality expectations and compliance actions.

· Lead issuance of lot numbers and associated GMP documentation; ensure readiness of documentation for QA release activities.

· Support the review of quality system records, such as deviations, CAPAs, and change controls, ensuring accurate and compliant documentation.

· Actively contributes to continuous improvement initiatives by identifying documentation gaps and proposing process enhancements.

· Work within controlled cleanroom environments with exposure to biohazards and chemicals, adhering to PPE and gowning requirements.

· Demonstrate ownership and accountability for assigned quality tasks in a fast-paced, evolving environment.

Key Skills: GMP/GDP compliance, deviation/investigation review, aseptic manufacturing, document control, batch record review, MasterControl, cell therapy QA, cross-functional collaboration, cleanroom operations, regulatory inspection readiness.

• On-site chemist utilizing logbooks, testing assays, and visual inspection to identify various commercial and residential chemicals for later sorting and processing.
• Responsible for site setup and proper flow between material sorting to first, second, and possible third round of sorting depending on site specification.
• Working knowledge of Chemical identifiers, preventing possible hazardous interactions between materials, and working knowledge of DOT Hazmat regulations for loading of materials.

· Conduct viral clearance studies in accordance with GLP, GDP, CFR, and SOP guidelines, focusing on nanofiltration and column chromatography techniques.

· Prepare and perform insect & mammalian cell cultures for API-Virus interference, excipient toxicity, and final product formulation titration assays.

· Perform basic maintenance and inter-study changeover of AKTA FPLC systems (AKTA Explorer, Avant 150, Avant 25); proficient in Unicorn software.

· Prepare reagents/media and maintain detailed equipment cleaning and maintenance logs to ensure audit readiness.

· Acted as lab lead for daily workflow coordination, troubleshooting, and scheduling.

· Serve as a Qualified Trainer for onboarding and mentoring new laboratory personnel.

· Accurately complete documentation in compliance with Good Documentation Practices (GDP).

· Initiate and write Non-Conformance Reports (NCRs), Change Controls, and support laboratory investigations.

· Contribute to internal and external R&D studies and support validation efforts for Remote Viral Clearance operations.

· Collaborate closely with Study Directors and managers to report findings and improve study execution.

· Maintain adherence to safety procedures and PPE protocols in BSL 2, BSL 2+, and BSL 3 lab environments.

Key Skills: Mammalian cell culturing, sample preparation, AKTA FPLC systems, column chromatography, nanofiltration, Unicorn software, GLP/GDP compliance, reagent preparation, documentation (GDP), lab equipment maintenance, team leadership, training.