Employment Classification : Regular/Permanent
Job details :
Orano Med is seeking a Production Lead to support the production of commercial radiopharmaceutical products at the ATLab Indianapolis site. Orano Med, a subsidiary of the Orano Group, is a fast-growing biotech company focusing on the development of targeted alpha therapy, an innovative class of pharmaceutical agents to combat cancer. Based on strong clinical results, Orano Med is preparing for commercialization by opening a new, state-of-the-art facility in Indiana, where Orano Med will manufacture therapeutic radiopharmaceuticals from its drug pipeline. Orano Med is looking for people passionate about fighting cancer to join our team! Reporting to the Senior Production Manager - Therapeutics, the Production Supervisor will assist in developing procedures for routine commercial manufacturing of Orano Med products. The Production Supervisor is responsible for managing production associates/activities, timely reporting of production deliverables, and timely implementation of the production schedule. Primary Responsibilities Managing production associates, including escalations to the Sr. Production Manager - Therapeutics Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed. Provide support to process experts / process owners including, SOP writing and revision, execution of qualification protocols, and batch records. Daily / Weekly reporting of production activities and escalation of delays on the production floor. Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging. Support equipment qualifications and improvement projects. Support the execution of process validations. Provide guidance, support, training, and knowledge to Production team. Expanded Responsibilities: Take a leadership role in production team deliverables and projects Work with other employees on the Production and Quality teams. Work with Quality Unit to ensure readiness for inspections. Maintain compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies. Working as an active member of the production team on the floor, when needed. Review and approval of production batch documentation. Ensure Production teams cGMP and GDP training compliance, daily.
OranoMed is seeking an Operator, Production for the production team at ATLab Indianapolis ("ATLab IND"), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. The top priority for the Production Operator will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. Prior to routine operations:
Work with Production team to improve the process
Writing/reviewing relevant SOPs
Implement new equipment, materials, software, systems
Environmental qualification of new cleanrooms
Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer Once production begins:
Top priority: Daily routine production o Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc. o Manufacturing activities following SOPs, using proper aseptic technique o Setup production; line clearance; clean/VPHP o Troubleshoot urgent problems o Identify, document, communicate failures/near misses
Quality/continuous improvement o Adhere to SOPs, company policies, regulatory requirements, laws o Work closely with QC/QA to deliver quality product o Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections
Cross-train and perform o Cleanrooms: cleaning, EM, restocking o Packaging/labelling/driving/shipping of radioactive product o Routine radiation surveys, wipe tests
Other o Maintain paper/electronic batch records, equipment logs, other records o Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting o Maintain stock of materials/supplies; receive deliveries; obtain documentation for raw material release o Recruit/train new employees o Other tasks as needed
Adress : Brownsburg
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