Alexion Pharmaceuticals Inc Senior Engineer II, Tech Transfer in New Haven, Connecticut

Alexion Pharmaceuticals, Inc.Alexion is an Equal Opportunity/Affirmative Action Employer.Req ID: 5225Job Category: Technical OperationsLocation: New Haven , CTPosting Date: May 16, 2017This position can be located in New Haven, CT or Smithfield, RIPosition Summary This position will support technology transfer for new or existing drug substance manufacturing processes to internal or external manufacturing sites. The position is responsible for providing strong technical, process validation and project management leadership for all aspects of support for technology transfer to drug substance manufacturing activities at internal or external facilities worldwide. Responsibilities also include providing support for regulatory submissions related to commercial products.Principal ResponsibilitiesEffectively lead technical transfer and process validation to ensure alignment with CMC schedule to meet with corporate goals and metrics, as required. This includes continuous communication with Quality Assurance, Quality Control, Process Development, Analytical Sciences, Supply Chain and CMO teams to ensure efficient tech transfer of Alexion's commercial drug substance manufacturing activities.Provide technical, process validation and project management leadership for both internal/external technology transfer teamsLead development, maintenance and continuous improvement of process validation activities for drug substance manufacturing processes including successful filing and approval.Additional activities include monitor/trend process performance, use appropriate statistical analysis tools for Product and Process Comparability.Coordinate cross-functional projects involving technical transfer, lead internal and external transfer meetings, manage project schedule and track progressAuthor and /or review technical documents in support of process tech transfer including deviations, CAPA and Change Control.Assemble reports for regulatory submissions. Review IND, BLA and other technical documents for regulatory agency submissions. Serve as a subject-matter expert on technology transfer and process support during regulatory agency inspections.Ensures the transfers are executed "right at first time" and the effective handover of validated process to Tech Services group.Global role with international travel (30%)Qualifications8-11 years of process validation and tech transfer experience in biopharmaceutical organization with in-depth technical and operational knowledge of multiple unit operations including cell culture and chromatography.Experience in collaborating with contract manufacturing companiesExperience in project managing small and mid-sized projects in conjunction with a CMOComprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliantMust be able to analyze data using statistical methodsResolve manufacturing issues and discrepancies in collaboration with Quality organizations internally and externallyMust be flexible and able to manage multiple tasks effectively while prioritizing appropriatelyAbility to drive for results independently and adapt to rapidly changing prioritiesExcellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partnersAbility to present and defend technical aspects of manufacturing operations during regulatory agency inspectionsAbility to influence others without direct authority and communicate with all levels of the organizationAbility to participate in global cross-functional teams and work effectively in a highly matrix team environmentMust be flexible and able to manage multiple tasks effectively while prioritizing appropriately.Education MS or PhD Degree in Engineering (Chemical, Mechanical) or Scientific disciplin