Emily Sheppard Email and Phone Number

• Project management of new combination product introductions (current projects include three new ophthalmic solutions and a nasal spray emulsion product); working with both internal and external R&D departments to take products through from exhibit batch manufacture to commercial production.• Management of a team of Validation Specialists: scheduling and technical oversight of all site thermal mapping qualification activities (both new equipment installations and routine re-qualifications, including: autoclave, Steam In Place (SIP), controlled room and product shipment temperature mapping).• Design and implementation of new site policy documents e.g. risk assessment of incoming product contact materials against extractable / leachable safety guidelines.• Providing technical problem solving leadership for both development and commercial scale activities.

• Established an annual re-qualification programme for 42 individual SIP systems and subsequently managed resource, equipment procurement/calibration and scheduling whilst maintaining technical oversight and control of validation certification.• Implemented and subsequently managed an annual ‘Validated Status’ review of all site temperature controlled facilities e.g. warehouse racking, cold stores, freezers etc.• Used lean principles to standardize validation processes and continuously improve ways of working. • Leadership of a team of Validation Technologists; first line management responsibilities e.g. staff training and development. Attended Coaching and Mentoring training.

• Project managed the development and qualification of new manufacturing schemes within a production environment; led a project team responsible for pilot-to-production scale up studies, manufacture of 3 exhibit batches and compilation of regulatory submission documentation for a new emulsion product.• Researched Quality by Design (QbD) principles and implemented a new procedure to provide a framework for documentation of the QbD product development lifecycle.• Generated batch manufacture documents and procedures.• Project Management training and ILM Level 3 First Line Management qualifications

I joined the NPD department at Teva Runcorn in 2008 as an analytical scientist; I was responsibile for developing and validating HPLC and other analytical methods. After 18 months in this role I joined a small of team of process and formulation scientists. I was responsible for early stage development of new product manufacturing schemes, which involved designing and executing pilot-scale manufacturing trials.