Isaac Bello

Research and Development Specialist @BWXT

Ottawa, ON, CA

Inspected all documentations for the submission of a new drug application (NDA) to the US FDA, ensuring compliance with cGMP and regulatory standards and requirements following GDP. Worked closely with the QA and RA teams to document deviations, CAPAs, and procedural deficiencies, as applicable.• Commissioning and licensing of BWXT’s electron beam (e-beam) accelerators (documentation development, safety system validation, dosimetry studies).• Prepared and executed installation and operational qualifications of radiopharmaceutical manufacturing equipment.• Reviewed and executed environmental monitoring procedures for viable and non-viable parameters for process qualification (IOQ/EMPQ) in classified (ISO 5, 7, & 8) facility areas.• Developed a trending sheet for data trending and record keeping for all testing and experimentation conducted during development of new processes.• Worked with the BWXT health and safety team to make sure SOPs and STMs are compliant with the BWXT EHS regulations as well as compliant with CNSC’s regulatory requirements.• Shadowed EHS compliance specialists for incidence reporting and completing workplace safety incidence reports.• Worked with the EHS team to ensure proper chemical storage, containment, and handling of corrosive materials, including hazard assessments and documentation for record keeping.• Worked with the EHS team to ensure sound levels in the work area are within the required decibel limit through noise mapping.• Collaborated with the engineering team to create manipulator-compatible tools and fittings designed for hot-cell operations.• Conducted cleaning validation studies for radiopharmaceutical manufacturing equipment.• Technical lead and point of contact for resolving manufacturing process issues with external vendor.• Resolved technical issues when they occurred by troubleshooting and implementing changes to SOPs.• Trained and mentored new staff on new equipment use, and maintenance routines.

Ahmadu Bello University

Bachelor of Science (B.Sc.) (Verified by WES), Chemistry

Ahmadu Bello University

Doctor of Philosophy (PhD) (Verified by WES), Organic Chemistry

Ahmadu Bello University

Master of Science (M.Sc.) (Verified by WES), Organic Chemistry

Algonquin College of Applied Arts and Technology

Graduate Certificate, Regulatory Affairs