Miriam
Ekwuru

Summary

I lead microbiology and quality operations in pharmaceutical and biotech manufacturing, with deep expertise in cell and gene therapy. Over 8 years, I've managed site-wide environmental monitoring programs, led quality investigations from root cause through CAPA closure, and served as a subject matter expert during FDA Pre-Approval Inspections. I've built compliance frameworks across multiple FDA regulations and EU standards, ensuring inspection readiness while driving continuous improvement in GMP operations. My work spans the full product lifecycle—from clinical-stage manufacturing through commercial readiness.

Experience

1. 2025-Present

   Microbiology Manager

   Velocity Bioworks · San Antonio, TX

   • Lead site-wide Environmental Monitoring (EM) and Microbiology operations, overseeing program execution, personnel, scheduling, and compliance activities supporting GMP manufacturing.
   • Own the Environmental Monitoring and Microbiology programs, including sampling strategies, alert/action levels, data trending, investigation support, and program improvements.
   • Develop, implement, and maintain EM/Micro strategies aligned with cGMP, FDA, EU Annex 1, USP <1116>, and internal quality standards.
   • Drive operational readiness for cleanrooms, gowning qualifications, microbiology lab activities.

2. 2024-2025

   QA Specialist IV - Investigations

   Scorpius Biomanufacturing · San Antonio, TX

   • Managed quality investigations from initiation through closure, evaluating deviations and non-conformances, performing root cause analysis, and driving appropriate corrective and preventive actions.
   • Reviewed CAPAs for adequacy and effectiveness, partnering with process owners to address identified root causes and reduce recurrence.
   • Served as a QA investigation SME during internal and external audits, coordinating auditor requests, facilitating documentation retrieval, and providing technical responses.
   • Revised and developed deviation and non-conformance procedures to improve consistency and strengthen quality system processes.

3. 2023-2024

   QA Specialist III

   Cell Ready LLC (formerly Marker Therapeutics, Inc.) · Houston, TX

   • Provided QA oversight throughout clinical-stage cell therapy operations, including apheresis receipt, manufacturing activities, finished drug product disposition, and shipment.
   • Performed donor eligibility assessments and dispositioned starting material in accordance with applicable requirements and established procedures.
   • Coordinated with Sponsors and cross-functional teams regarding apheresis receipt, donor documentation, product release, and shipment activities.
   • Oversaw Chain of Custody and Chain of Identity activities to maintain product traceability and cGMP compliance throughout manufacturing operations.

4. 2022-2023

   QC Specialist III

   Marker Therapeutics Inc · Houston, TX

   • Provided QC oversight of laboratory activities and documentation to maintain compliance with GMP and GDP requirements.
   • Supported mock and Pre-Approval Inspection (PAI) preparation by reviewing documentation and assisting with inspection readiness activities.
   • Partnered with QA to design and execute equipment and material qualification protocols supporting laboratory operations.
   • Investigated Environmental Monitoring excursions and other QC non-conformances, performing root cause analysis and supporting CAPA implementation.

5. 2020-2022

   QC Specialist - Environmental Monitoring

   Marker Therapeutics Inc · Houston, TX

   • Executed routine viable and non-viable Environmental Monitoring activities supporting aseptic manufacturing and facility qualification.
   • Collected, processed, and analyzed environmental samples and evaluated results for potential excursions and trends.
   • Initiated and investigated EM deviations, non-conformances, and OOS results, escalating issues in accordance with established procedures.
   • Performed microbiological testing, including media growth promotion, Gram staining, and pH testing.

6. 2019-2020

   QC Microbiologist Analyst II - Environmental Monitoring

   Lonza Biologics Inc · Houston, TX

   • Performed environmental and personnel monitoring of cleanrooms supporting engineering and GMP manufacturing runs.
   • Performed microbiological testing supporting media and product release and coordinated microorganism identification activities.
   • Performed water and compressed gas sampling and supported Environmental Monitoring Performance Qualifications prior to room release.
   • Trained and evaluated new hires and supported laboratory readiness for audits and GMP operations.

7. 2018-2019

   Senior Pharmacy Quality Control Technician

   Avella Specialty Pharmacy · Houston, TX

   • Performed viable and non-viable Environmental Monitoring and personnel monitoring for aseptic gowning qualification in controlled cleanroom environments.
   • Operated particle counters and microbial air samplers while verifying calibration status and maintaining compliant documentation.
   • Supported EM documentation, cleanroom activities, and quality auditing in accordance with cGMP and site procedures.
   • Supported laboratory in autoclaving cleanroom supplies.

8. 2017-2018

   Manufacturing Technician

   Osiris Therapeutics Inc. · Colombia, MD

   • Performed sterile and aseptic manufacturing activities for tissue products in accordance with GMP/GTP requirements, batch records, and SOPs.
   • Supported manufacturing documentation, inventory activities, technology transfer, equipment preparation, and coordination of QC sample testing.
   • Identified areas for improvement in manufacturing efficiencies and compliance and initiated Change Controls for implementation of improvements.

Skills

Education and certifications