Ralph Blackmer

Ralph is an accomplished global Pharmaceutical Quality, Manufacturing/Supply, Product Development, and Regulatory Compliance thought leader with a track record of successfully organizing and executing major strategic initiatives with corporate-level impact.

He has broad global and domestic experience across pharmaceutical manufacturing and development as a practitioner and hands-on leader.

Ralph holds a PhD in Pharmaceutics, MS in Management Science and Engineering, and a BS in Chemistry. He is a Certified Lean Sigma Green Belt.

Ralph has been an invited lecturer for Japanese MHW Inspector training and Pharma China SFDA training. He lectures on Supply Chain Management and Security at Villanova University.

He has extensive interaction with the US FDA and with regulatory agencies worldwide including pre-approval and for-cause inspections and response to inspectional observations and actions including Warning Letters and Consent Decree.

He has held a number of senior positions in the industry, including Head, Corporate Integrity Program Office, Vice President Technical and Analytical Sciences; Vice President Quality Center of Excellence; Vice President Strategic Manufacturing Alliances & Procurement; Vice President Worldwide Regulatory Compliance, Director, Pharmaceutical Technologies; Manager Chemical and Pharmaceutical Production.

Examples of projects completed:

Led Compliance Improvement Team for major US supplying site under Consent Decree, served as single point of contact between site and FDA, met all time-critical requirements, site was remediated to acceptable GMP status.

Established and led Corporate Integrity Agreement Program Office; significant interaction and correspondence with FDA, successful resolution of multiple Warning Letters. Conducted multiple major Due Diligence assessments in association with Business Development and Scientific Licensing projects in Japan and India.

Led major QMS revision resulting in streamlining, simplification and harmonization of compliance standards across businesses. Leaned, improved and blueprinted processes for Batch Record Review, Change Control, Laboratory Operations, Risk Management, Incident Management and CAPA.

Key member of validation and commissioning team for new 180,000 sq.ft. aseptic freeze drying facility launched with no 483.

Successfully transitioned major new products from clinical development to commercial manufacturing.

Audited operations, trained and coached staff at sites In Italy and UK supplying US ahead of major FDA inspections with successful outcomes