Manufacturing, Science and Technology Specialist - #1405280

The Manufacturing, Science and Technology (MSAT) Specialist will play an essential role in driving collaboration between the research and development, manufacturing, training, etc. teams allowing for the introduction of new projects and transfer of existing projects from R&D to GMP facilities dedicated to theragnostic radiopharmaceutical manufacturing. This individual will perform tech transfer related and support function tasks including, but not limited to, the ordering and commissioning of new equipment/consumables and processes to meet sponsor requirements while also supporting operational readiness. The MSAT Specialist will also be responsible for training new and existing staff members on equipment and processes, while also assisting quality with any process deviations as a subject matter expert. PRINCIPAL RESPONSIBILITIES: Proactively works cross-functionally with teams such as R&D, quality, and safety to onboard new equipment and processes for manufacturing of radiopharmaceuticals. Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS. Writes documentation such as, but not limited to user requirement specifications, system classifications, risk assessments, IQ/OQ/PQs, operational SOPs, batch records, training OJT/OJQs, logbooks, etc. Develops and delivers phase appropriate product understanding and control strategies. Working with Supply Chain individuals, orders consumables and spare parts needed for equipment and processes. Assists with engineering/maintenance support. Supports manufacturing of radiopharmaceuticals throughout the product lifecycle. Demonstrates willingness to be flexible and adaptable to the needs of the department and business. Ensures internal/external sponsor expectations are met or exceeded. Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance reports. Ability to tech transfer equipment/processes to future facilities. Drives optimization of production efficiencies and capabilities by creating material workflows, room layouts, while also developing continuous process improvements. Performs other job-related duties as assigned.