Employment Classification : Regular/Permanent
Job details :
Orano Med is a leading innovator in the field of isotope and drug product manufacturing, dedicated to enhancing patient care through advanced therapeutic solutions. We are committed to excellence in our operations and are looking for a passionate and experienced Manufacturing, Science and Technology Specialist to join our team.
The MS&T Specialist will assist in all technical aspects of isotope and drug product manufacturing. This role will contribute to the alignment among facilities, execute technical transfers to new manufacturing sites, train manufacturing teams, and implement new processes developed by R&D. The ideal candidate will possess a strong background in pharmaceutical manufacturing engineering and cross-functional collaboration.
Primary 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.

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Adress : Brownsburg