Primary Duties: Under the direction of the Sr. Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Mange submissions and interactions with the FDA and...

Primary Duties: The individual is expected to provide leadership and management to one of the cell culture floor support groups within Manufacturing Sciences and Operations Support (MSOS). The key support services, deliverables, and capabilities...

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...