Sr Development Engineer - Upstream Commercial Support

Primary Duties: This individual will work with a group of scientists and engineers to provide cGMP manufacturing technical support and continuous process improvements for the upstream cell culture processes of the commercial products of Shire Human Genetic Therapies. The scope of work will include supporting GMP investigations and change controls, designing and executing experiments, authoring memos and technical reports, and improving manufacturing processes to reduce reoccurring deviations. The focus of the work will be upstream cell culture, cell harvest, and UFDF. This individual will interact extensively with other departments including Manufacturing MTS, QA, QC, PD, Supply Chain and Engineering. Responsibilities: 50% - Design, Plan and Execute experiments aimed at finding root cause, assessing potential impact to product quality, justifying change controls, and improving the process. 20% - Provide technical leadership and support for complex GMP investigations and various other issues. Make recommendations when needed. 20% - Author study proposals, research and development reports, and various technical memos. 10% - Project management Education and Experience Requirements: A MS degree in Chemical Engineering, Bioengineering, or related disciplines with a minimum of 4 years relevant experience in bioprocess/pharmaceutical environment is required. For BS degree a minimum of 7 years experience is required. Experience with cell culture and bench scale bioreactors is a must. Deep understanding of the large scale cell culture process required. Experience with cGMP manufacturing and cGMP quality systems strongly preferred. Experience with perfusion cell culture process a strong plus. Experience with large scale roller bottle processes preferred. Key Skills and Competencies: The successful candidate must: * Have strong skills in designing and executing small scale cell culture experiment in bioreactors, culture bags, and other culture vessels. * Have in-depth knowledge of large scale cell culture processes * Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues. * Have excellent written and verbal communication skills. Feel comfortable working in various cross functional teams. * Be able to lead complex investigations or manage projects with minimal supervision. * Be able to coach junior staff on design and execution of experiments. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer