James Shanley

Career Break

• Responsible for process performance monitoring through review of manufacturing and quality data to address potential anomalies or adverse trends.
• Authored and supported CAPA investigations, documenting Root Cause Analysis, technical rationale and appropriate resolutions.
• Provided functional area review and disposition of designated product test results.
• Assessed and reported aberrant/failing test results informing stakeholders and management of quality impacting issues.
• Created and reviewed process documentation including operating procedures, manufacturing batch records, investigation/qualification protocols and laboratory investigation work instruction sheets.
• Acted as Principal Investigator for an Internal Whole Blood Specimen Collection Program to facilitate testing of diagnostic reagent.

• Supported Bulk Reagent manufacture through involvement in both project and CAPA driven updates including fill line qualifications, material and commodity validations and design plan and process community participation.

• Facilitated successful transfer, qualification and implementation of an Abbott specific diagnostic concentrate manufacturing process requiring inter-site collaboration and extensive training.
• Included product manufacture, creation and roll out of training material, CAPA processing and equipment procurement/qualification.

• Provided technical support for laboratory practical sessions including culture collection maintenance, media preparation, protein isolation and purification and small scale fermenter operation.

• Involved in technical transfer and manufacturing implementation of a developmental gene therapy product in collaboration with US based Biotechnology company.
• Manufactured cell culture by fermentation for protein production with intended use in treatment of cardiovascular disease.

• Responsible for manufacture of reagent components for rapid membrane and microtitre plate immunodiagnostic products involving conjugation of synthetic peptide, enzyme labeling and protein purification/isolation.
• Involved in procurement and validation of new equipment and revision review of site documentation.

• Processed large volume culture batches of microbial strains by deep tank and solid media fermentation for wastewater treatment product manufacture.
• Responsible for microbial colony isolation, inoculation preparation, pilot to large scale bioreactor, total plate count and contamination assessment.