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. 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.  

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.

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.