Jeffrey Dougherty Email & Phone Number

Subject Matter Expert developing oral dose products including formulation, process development, batch scale-up and technology transfer through validation. Experienced for 30+ years with three major pharmaceutical companies as laboratory and project team leader and as liaison for transfer to other departments and locations. Collaborated with third party organizations for product development, technology transfer and product manufacturing. Strong communications skills and ability to work effectively at all levels internally and externally.CAREER HIGHLIGHTS• Experienced with actively collaborating with multiple teams (research, manufacturing, analytical, regulatory, engineering, quality, etc.) developing /transferring/modifying new and existing products to commercial manufacturing sites using Quality by Design, Lean Sigma techniques, and in accordance with ICH and cGMP guidelines to produce quality products to meet customer requirements.• Formulated dry granulated oral product, scaled up in pilot lab to produce robust and reliable product design resulting in commercial production with in the first 200+ batches released without an OOS or OOT test result.• Instrumental in process development of fixed dose combination tablet-in-capsule leading to transfer to in-house manufacturing site producing $300,000 savings from contractor manufacturing costs.• Developed oral products; adult (immediate and modified release) and pediatric (chewable and minitablets).• Authored documents for all stages of development such as:o Target Product Profiles o Risk Assessmentso Development Study Protocols and Reportso Validation Protocols and Reports o Laboratory and commercial manufacturing floor experience in technology transfers