•Support parenteral technology transfers by participating in tech transfer teams and authoring key enabling documentation. •Support authoring and optimization of tech transfer business processes •Collaborate with cross functional teams, including R&D and Contract Manufacturing Organizations (CMO’s)•Assess both internal and external manufacturing capabilities against current BMS and industry technical standards for advanced commercial aseptic processing.•Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities.•Review and verify CMC filings (US and ROW).•Knowledge of parenteral/sterile manufacturing.•Very strong analytical, technical writing, verbal communication.•Ability to influence areas not under direct control to achieve objectives.

• Develops and improves departmental procedures, including procedures for technical transfer, continued process verification, client communication, project assessment, etc. • Initiates Quality Records and conducts deviation investigations that meeting both Industry and Paragon expectations.• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments.• Develops, executes and oversees CAPAs.• Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.• Supports Tech transfer and process monitoring support as needed.• Works with the team to monitor critical process parameters.• Revision and management of manufacturing documents such as Batch Records and SOPs.• Leads or supports Continuous Improvement projects.• Conducts data gathering, trending, and data presentation as needed to support investigations.• Responsible for real-time, on the floor response in support of operational deviations by gathering information and completing an initial event report.