Senior Biotech Consultant, Pharma and Biotech
Pharma and Biotech
Phil Lynch has over 30 years of quality and regulatory affairs management experience in the pharmaceutical, medical device, ISO 9001 and cannabis (regulated) industries in multi-site plant operations oversight and corporate offices.
Phil has supported many pre-commercial/clinical stage organizations most recently as Head of Quality and Regulatory Affairs at Precision NanoSystems, a pre-clinical, Ph1/2 SaRNA CDMO and liquid nano-particle equipment manufacturer. He has consulted for several large and small molecule companies from pre-clinical through to commercialization.
Phil is an expert in full quality system development, implementation and remediation and specializes in investigation management, batch disposition, change control, validation/qualification, and vendor management. He can support phase appropriate scale at any stage of development.
His areas of expertise include:
- QMS development, implementation, and remediation support
- Investigations and deviation management
- Sterile manufacturing (aseptic and terminal sterilization)
- Clinical stage QA support
- Greenfield site and QMS development
- CDMO/CMO/vendor qualification and management