Careers

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.

The Sterility Assurance Specialist is responsible for maintaining sterility assurance processes and ensuring compliance with industry standards and regulations. They collaborate with cross-functional teams to develop and implement bioburden reduction strategies, perform risk assessments, and address microbiology-related issues. Key Responsibilities: Technical Expertise: Provide technical expertise in bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices. Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers. Develop responses to microbiology and sterilization-related requests and audit findings. Risk Assessment and Root Cause Analysis: Conduct risk assessments related to sterility assurance and microbiology. Perform root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues. Develop corrective and preventive actions to address identified risks. Compliance and Standards: Maintain compliance with relevant regulations (e.g. 21 CFR Part 210/211). Ensure adherence to industry standards and best practices. Collaborate with internal and external stakeholders to align processes with guidelines. Quality Control and Audits: Regularly audit personnel and processes for bioburden control and sterility assurance. Manage and evaluate ISO classification activities, media fills, and gowning validation processes Perform trending and analysis of environmental monitoring and other microbiological data for management review and continuous improvement Team Leadership and Training: Provide guidance, training, and support as needed to operators in support of aseptic and sterile operations. Foster a culture of quality and compliance within the team.

OranoMed is seeking a Production Operator 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 Remote work may be possible during the period the facility is under construction. 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

The Safety Officer manages the Radiation Safety, Chemical Safety, and Environmental Health & Safety programs and serves as the subject matter expert for safety regulations impacting the various departments.  Duties include developing policies and procedures in accordance with applicable regulatory entities. Primary Job Duties:  Radiation Safety Officer Formulates, prepares, and implements the Radiation Safety Policies and Procedures. Implements the Radiation Worker Training program and provides Radiation protection oversight. Trains employees on radiation safety procedures. Reviews and maintains historical record of area surveys. Tracks, trends and reports radiation exposure of employees and area radiation surveys. Manages employee radiation exposure badges and electronic dosimeters Maintains inventory of radioactive materials (RAM), RAM receipt documentation, RAM shipping documentation and usage logs. Performs periodic equipment and sealed source checks to comply with applicable regulations. Regularly inspects facility and audits practices for radiation safety compliance, addressing any concerns promptly. Maintains DOT and Hazmat certification for compliance with radioactive material shipments – domestic and international. Chemical Safety Officer Formulates, prepares and implements the Chemical Hygiene Plan to ensure regulatory compliance as mandated by local, state, and federal agencies. Formulates, prepares and implements chemical safety policies / programs such as proper chemical inventory, labeling & storage procedures, chemical material disposal, and chemical implications for fire protection. Ensures proper chemical or hazmat spill preparedness & clean-up supplies are kept in stock. Conducts routine and follow-up chemical safety and hazard inspections throughout the facility ensuring adherence to established procedures and proper operation of chemical hoods, eyewashes, safety showers and other emergency equipment. Responds to emergency situations involving hazardous materials, or fire and smoke incidents; prepares reports of findings and submits recommendations. Analyzes chemical accident and incident reports for trends; makes recommendations for correcting unsafe conditions and actions. Environmental Health & Safety Officer Develop, manage & maintain the Environmental Protection, Safety, and Health plan. Perform process, jobs, and work site hazards analysis and reviews, and define the hazards controls to be integrated during planning activities, and implemented during process development, work instructions development, and work execution. Monitor and evaluate activities and work areas, and address safety issues and concerns with employees; provide feedback into the work processes of issues observed. Capture and report safety incident notifications, investigations, and the root cause. Track and report company Safety Key Performance Indicators. Maintain continuous improvement of the the Company's Safety Culture.

The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help cancer patients. Primary Responsibilities: Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed. Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records. Collect data for process qualification and implementation. Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging. Support process optimization, development of new processes, and introduction of new technologies. Lead equipment qualifications and improvement projects. Support the execution of process validations. Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house. Provide guidance, support, training, and knowledge to Production team. Expanded Responsibilities: Take a leadership role in managing multiple projects. Work with other employees on the Production and Quality teams. Coordinate internal resources and third parties. Supervise work of contractors. Create/maintain comprehensive project documentation. Work with Quality Unit to ensure readiness for inspections. Ensure that all activities are in compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies. Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team. Support cross-functional teams to address all site-related activities, such as urgent events that regulations, and Orano Med Policies. Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team. Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.

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.

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. OranoMed is seeking a Senior Clinical Project Manager for its clinical trials. The Senior Clinical Project Manager is responsible for the oversight of assigned clinical trials and associated activities ensuring that they are executed, conducted, and completed in accordance with corporate goals and objectives, applicable regulations, and Standard Operating Procedures (SOPs). The Senior Clinical Project Manager functions with minimal supervision, collaborating with inter- and intra- company resources to ensure quality performance and that project timelines and needs are being met. Main responsibilities include: • Evaluate and oversee the activities required to execute, conduct, and complete clinical trials while managing to the established timelines and corporate budgets. • Function as primary liaison for vendor personnel, site personnel, and internal personnel regarding trial related topics and/or questions. • Negotiate site budgets and contracts. • Collaborate with cross functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, and quality assurance). • Manage trial start-up activities by providing input in protocol development, case report forms (CRFs) and study related material and independently developing the Informed Consent (IC). • Develop, implement, and ensure adherence to the monitoring plan for assigned trials. • Ensure the collection, accuracy, and storage of trial related documents. • Oversee trial monitoring activities for assigned trials and personally conduct site visits as needed. • Conduct regular team meetings, assigning action items and due dates, as applicable. • Review and track monitoring reports for content, quality, adherence to GCP and timely submission. • Identify obstacles and related solutions and implement plans, in collaboration with the study team, to ensure the trial objectives, scope and timelines are being met. • Develop Corrective and Preventative Action (CAPA) plans for issues of non-compliance. • Track, measure and report the status of project milestones. • Assist in the development and implementation of clinical Standard Operating Procedures and associated tools. • Other duties as assigned.  

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 Description: Orano Med is searching for an energetic and highly motivated professional to participate in manufacturing of current Good Manufacturing Practices (cGMP) clinical products as GMP Production Associate. This position will perform functions related to production and GMP manufacturing operations, including preparation of clinical doses. This position requires great attention to detail, ability to work in a team environment and interest in optimization of processes. The GMP Production Associate will be responsible for adhering to Standard Operating Procedures (SOPs), cGMPs, and all safety requirements involving use of radioactive materials. Major Duties and Responsibilities: Perform radioactive isotope elution and chelation as part of GMP manufacturing according to written procedures. Maintain batch records, equipment logs, and other production records as directed per company procedures. Work concurrently with Quality Assurance personnel to deliver a quality product. Follow and adhere to production schedules and timelines. Execute room and equipment preparation for manufacturing operations. Maintain stock of manufacturing raw materials and obtain necessary documentation. Identify and communicate process failures during manufacturing. Identify common equipment/process failures and troubleshoot solutions for operational challenges. Assist in deviation investigations, corrective actions, and preventive actions. Clean, sanitize and sterilize equipment and components to support production operations. Perform room sanitization activities as needed to maintain controlled environment conditions.