Careers

The Process Engineer 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.

Job Description: The Associate Director, Quality Assurance supports the Company's short- and long-term goals for maintaining Quality Systems and Compliance. Provides direct oversight for the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. This role oversees quality assurance of the manufacturing and packaging processes and procedures, the final review of investigations, and appropriate implementation of corrective actions to prevent recurrence. This role also provides input into the overall decision-making process pertaining to quality problems, internal and external, that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs. Job Duties: Provides daily oversight of the QA teams responsible for supporting all production/processing areas. Develops and monitors appropriate KPI's for batch documentation review, Right First Time (RFT) and support of timely batch release. Responsible for department resource planning, talent development, and budget administration with regards to QA personnel. Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures. Provides QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports. Ensures completeness, accuracy and compliance of all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs. Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.

Orano Med: Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells. Job Summary: Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. Job Responsibilities: Oversee IQ/OQ/PQ for new instruments Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports) Equipment/service logs: establish, review, maintain URS for equipment: Assist with drafting/review/approval Responsible for a variety of cGMP and non-cGMP instruments including:Production: preparatory LC, fluid transfer, dispensing, weighing, EM QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes Hot cells: VPHP, EM, fill/finish, other sensors/controls Safety: radiation detectors for personnel, surfaces, air General: refrigerators/freezers, incubators Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc. Work with instrument operators to develop robust protocols for system suitability checks for equipment Assist with vendor qualifications Top Priority: On-Time Production/Release of Product Batch Release All tasks from the Setup Phase that continue into Production Phase. Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status. Preparation of calibration certificates and data reports using appropriate Quality documentation. Ensuring that the equipment is calibrated as per specifications and industry standards. Oversee warranties, PMs, scheduled recalibration/requalification Scheduling appointments for equipment maintenance and servicing. Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks Testing repaired equipment to verify qualified status Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies. Expert on instrumentation: liaison to management/inspectors Write protocols for in-house calibrations/qualifications Analyze/suggest equipment upgrades and software Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.) Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.

Job Duties: Project Stage Priority: Facility buildout complete ProjectOn-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cells Support the installation/qualification of mechanical/HVAC, electrical, plumbing, cleanrooms, hot cells, fume hoods/isolators, control systems, BMS, fire safety, etc. Heavy emphasis on HVAC/cleanrooms/BMS Liaison with service providersPrimary point of contact; supervise on-site work Obtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationships Manage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services) Assist withSafety programs: radiation, laboratory, occupational Facility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical) Cleanrooms: Participate in cleaning, IQ/OQ/PQ Establish a system for scheduling/recording: warranties, inspections, PMs, repairs Production Stage Priority: Facility ready to produce GMP doses Continue tasks above, as needed On-call to react to alarms/emergencies/urgent facilities problems that might cause production delays Production area: Ensure safety and readiness Inspections/PM/repairs of facilities-related equipment: In-house or supervise contractors (e.g., emergency showers/eyewash, fire sprinklers/extinguishers, emergency alarms/systems, backup power transfer) Facilities equipment: Manage warranties, service contracts; schedule PMs, requalification Documents for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reports Maintain a stock of spare parts/other supplies Assist with budget forecasting of CapEx/OpEx Waste management: RAM, chemical, garbage, recycling Assist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs) Facility renovations/expansions: planning, bidding, selection/contracting, design, project management All Stages Frequent facility inspections inside/outside[HE(C5]  Expert on the facility for inspectors/management/staff Review/approve documents: quotes/contracts, PMs, final reports, invoices Manage badge access system Attributes o Character to exemplify: integrity, team spirit, service attitude, initiative, problem solving, attention to detailEmbody a culture of safety, quality, continuous improvement, customer service Press toward ambitious goals/timelines; motivate colleagues Comply with SOPs, policies, regulations, laws Represent employer well at all times Location: On-site 100%; Travel <10% Other tasks/responsibilities as needed

Orano Med is seeking a Systems Administrator - Cloud to administer, monitor, and provide maintenance to the Firm's cloud based and internally hosted systems, to include O365/Azure. The employee will ensure that our systems are available, secure, and have documented and supported policies, procedures, and guidelines as directed. Tasks for the Systems Administrator may include but are not limited to: Maintain the highest level of operational standards for cloud technologies while executing best practices in operations and ongoing maintenance. Maintain plans and procedures for administration of the cloud based and on-prem systems. Maintain O365 environment to include Azure AD, Intune, Exchange Online, Teams, and OneDrive. Respond to tickets from the Service Desk that require Infrastructure support and follow appropriate ticketing procedures. Adhere to and follow Change Management Policy and procedures. Manage and complete onboarding process of new employees. Assist in management and deployment of end user and server patches and updates, including research of operational effects of the same prior to deployment Assist with data center operations, procedures and control mechanisms, documenting key controls such as physical and remote access. Receive and respond to system notifications such as Security, Compliance, or Performance notices, and take appropriate actions to remediate any problems that may occur. Test redundancy system and backup integrity as well as recovery procedures on a regular basis. Supporting remote workers / located at other sites Assist with the documentation of all system processes and procedures to ensure standardization, and best security practices. Assist with the build and maintenance of servers in the cloud environment. Automation of internal IT processes (Microsoft Power Automate, PowerShell)

Orano Med is seeking a Chemistry Technician I to support the scientific research performed as part of Orano Med preclinical Research and Development. The Chemistry Technician I will be responsible for helping chemists to develop, research and produce novel peptides and peptide conjugates with potential radiotherapeutic applications in support of the company's preclinical research activities. Works in laboratories, conducts experiments, and monitors synthesis processes.  Isolates and purifies intermediates and characterizes them by HPLC, LCMS, among others. Major Duties and Responsibilities The Chemistry Technician I will perform a variety of day-to-day tasks including but not limited to: Manual and automated solid-phase synthesis, purification, and characterization of peptides Synthesis of small to intermediate-size molecules using common organic synthesis techniques Use HPLC, LC/MS for peptide characterization and purification workflow Plan, execute, and document work under the guidance of a supervisor Organizes time to meet project timelines Ability to understand deadlines and commitments/ can effectively manage time in the lab Organized individual who can carry out tasks from start to end with little supervision, once properly trained on the task at hand Can communicate clearly in written and verbal forms Research literature to help solve problems associated with current and future projects

Orano Med: Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells. Position Summary: The Senior Clinical Project Manager is responsible for project management and oversight of assigned clinical trials. Position Responsibilities:  Oversight checks including monitoring report review and TMF checks. Status meeting attendance, meeting minute review/taking. Invoice review, confirmation of services received. Support CRO with site level issues including non-compliance, etc. Review data cleaning metrics, address backlogs. Review or create/amend study level documents including ICFs, protocols, study plans, training materials, etc. Provide study status updates. Manage study to budget and timelines. Other duties as assigned. ***Will be a remote position***

Position Summary: The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform. Job Duties and Responsibilities:  Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform. Select and onboard/implement an archival TMF platform. Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible. Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings. Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections. Stay current with regulatory requirements and industry best practices related to records management and TMF.

Position Summary: This role will be responsible for oversight of outsourced data management activities and be charged with developing data management oversight and data cleaning processes and a CRF library. Major Duties and Responsibilities:  Oversee outsourced data management activities by ensuring the design, development and maintenance of clinical databases meets regulatory requirements and industry standards and developing and monitoring key performance indicators (KPIs) for data management service providers. Ensure timely and appropriate reconciliation of external data sources against clinical databases on assigned studies. Collaborate with cross-functional teams including Clinical Operations, Biostatistics and Clinical Development to ensure high quality and on time delivery of study level data. Collaborate with internal stake holders to develop an internal data review process. Manage internal data review process and issuing / resolution of queries. Develop global CRF library for re-use on future studies to improve study database build timelines.