Miriam Osullivan Email & Phone Number | Manufacturing Director with a broad range of experience in: Quality Leading Cross Functional Teams. Validation Regulatory Filings Audits & Inspections Parenteral, biotech and API bulk pharmaceuticals. Aseptic Vial and Syringe Filling. Isolators, RABS and clean rooms. New Product Introduction & Tech Transfer Process validation. Packaging Validation. Automated Inspection. Formulation, Equipment and vessels. Cleaning Sterilisation -steam, heat and VHP. Automation (PLC, SCADA and MCS) Facilities (HVAC and utilities) qualification. Single use technology Biologics manufacturing PQA Tech transfer Change management Regulatory Inspection and preparation experience. Project validation lead from design, spec, FAT, SAT and qualification. Verification, commissioning and Validation using ASTM e2500. Coordination and lead for a multidisciplinary, cross functional team delivering projects within budget and to very tight timelines. Hiring, managements and retention of skilled project and sustaining resources.

Miriam Osullivan

Manufacturing Director with a broad range of experience in: Quality Leading Cross Functional Team...
Dublin, County Dublin, Ireland

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Miriam Osullivan’s Location Dublin, County Dublin, Ireland

Miriam Osullivan’s Current Industry Amgen

Miriam Osullivan’s Prior Industry Pfizer Grange Castle | Pfizer | Bristol Myers Squibb

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Senior Director of Manufacturing

2023-10-01 00:00:00 - Present

Validation and Commissioning Lead, Syringe Fill Finish, Grange Castle

2002-01-01 00:00:00 - 2011-12-01 00:00:00

Senior Validation Engineer

2002-03-01 00:00:00 - 2011-12-01 00:00:00

Validation Engineer

2000-01-01 00:00:00 - 2002-01-01 00:00:00

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Miriam Osullivan is a Manufacturing Director with a broad range of experience in: Quality Leading Cross Functional Teams. Validation Regulatory Filings Audits & Inspections Parenteral, biotech and API bulk pharmaceuticals. Aseptic Vial and Syringe Filling. Isolators, RABS and clean rooms. New Product Introduction & Tech Transfer Process validation. Packaging Validation. Automated Inspection. Formulation, Equipment and vessels. Cleaning Sterilisation -steam, heat and VHP. Automation (PLC, SCADA and MCS) Facilities (HVAC and utilities) qualification. Single use technology Biologics manufacturing PQA Tech transfer Change management Regulatory Inspection and preparation experience. Project validation lead from design, spec, FAT, SAT and qualification. Verification, commissioning and Validation using ASTM e2500. Coordination and lead for a multidisciplinary, cross functional team delivering projects within budget and to very tight timelines. Hiring, managements and retention of skilled project and sustaining resources.