David S. Email and Phone Number

Leading a team of drug product leads (domestic and international) that provide Tech Transfer, PPQ, and Life Cycle Management leadership to biologic & oligonucleotide products located in GSK's internal and external manufacturing network.

Product Leader in Biopharm & Steriles Manufacturing Science & Technology (an above site technical group) supporting the introduction of new parenteral drug products (including biopharms, small molecules, oligonucleotides, and antibody drug conjugates) to aseptic secondary manufacturing facilities within GSK and to CMO's.

Global Regulatory Affairs supporting license amendments to in-line vaccine products.

Drug Product Working Group (DPWG) Lead for the transition of products emerging from early clinical development into late-stage commerical manufacture.Project planning and execution for developmental engineering batches, stability batches, process performance qualification (validation) execution for two drug candidates part of MERCK's Product Pipeline in 2012 - 2015.Collaborated with both MERCK and Contract Manufacturing Organizations to lead the manufacture of sterile injectable… Show more Drug Product Working Group (DPWG) Lead for the transition of products emerging from early clinical development into late-stage commerical manufacture.Project planning and execution for developmental engineering batches, stability batches, process performance qualification (validation) execution for two drug candidates part of MERCK's Product Pipeline in 2012 - 2015.Collaborated with both MERCK and Contract Manufacturing Organizations to lead the manufacture of sterile injectable products. Demonstrated abilities in; program planning, investigation execution, deviation close-out, process demonstration, and development for new lyophilization processes. Show less

Subject Matter Expert (SME) to the controlled temperature unit (CTU) center of excellence (COE) chartered to establish governing principles for site-wide alarm strategy and deviationmanagement of >300 cold storage units at Merck's West Point facility in MMD. Technical Lead responsible for establishing a novel quality control assay for pre-filled syringes. Primary contact for all related regulatory agency discussions. Responsible for assessing and documenting technological… Show more Subject Matter Expert (SME) to the controlled temperature unit (CTU) center of excellence (COE) chartered to establish governing principles for site-wide alarm strategy and deviationmanagement of >300 cold storage units at Merck's West Point facility in MMD. Technical Lead responsible for establishing a novel quality control assay for pre-filled syringes. Primary contact for all related regulatory agency discussions. Responsible for assessing and documenting technological developments in assay development through vendor site visits internationally and domestically. Show less

Technical Manager of an investigative team (mixed contractor and full time work force) to assess events that occur in Distribution & Logistics (D&L) during the shipping of vaccine products to domestic and international sites; this includes hiring, mentoring, training direct reports and fiscal stewardship. My team directly supported the effective distribution of vaccine products totaling $4 billion in sales / 2010 world wide by immediately assessing deviations for root cause and product impact.

Provide technology support to Sterile & Packaging Operations by supporting product formulation, vial filling, and automated vision inspection to support significant increase of vaccine sales from $0.5 billion in 2004 to $4 billion in 2010. Including:◊ root-cause analysis,◊ process improvement,◊ alignment of operations with regulatory expectations

Planned and executed process validation testing for new liquid and lyophilized biological vaccine products. Coordinated and executed validation activities within Vaccine and SterileOperations including CIP/SIP validation of all equipment and components associated with formulation, filling, lyophilization of biological and sterile pharmaceutical products in asepticprocessing areas. Validated gamma irradiation sterilization processes.

Mentored and tutored undergraduate students in the Mechanical Engineering curriculum in the College of Engineering.

Litigation support services - construction delay analysis.