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 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 Manufacturing Technician. 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 technician 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.

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 Clinical Trial Manager for its clinical trials. The Clinical Trial 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 Clinical Trial Manager functions with general 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 is seeking a Sr. Analyst, QC for ATLab Indianapolis (ATLab IND), a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. The top priority for this position will be QC testing for same-day batch release. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. Setup Phase Training: SOPs, safety (radiation, industrial), on-the-job training for QC methods Assist with IQ/OQ/PQ of new equipment and instrument software; supervise/learn from field engineers when they are on-site Draft/review of documents: SOPs, Forms, FMECA, tech transfer protocol, analytical method validation protocols QC methods: tech transfer, implementation, improvements, full validation Production Phase Top Priority: QC testing for batch release within hours of production Routine Functions: All tasks from the Setup Phase that continue into Production Phase. Safety: Follow EHS regulations/guidelines, incl. NRC (ALARA), OSHA, EPA, chemical, waste disposal, etc. Adhere to SOPs, cGMP requirements, company policies, regulatory requirements Regulatory compliance: maintain constant readiness for inspection Maintain status as a qualified operator for all QC procedures Day-of-use setup before QC testing: Verify calibration/qualification status of instruments Gather raw materials and confirm not expired System suitability testing of instruments Testing: Chemistry QC: raw materials, APIs, in-process materials, finished drug products Microbial: VPHP, inoculation of drug product, incubation/inspection of samples for EM/sterility testing Carefully complete documentation: paper/electronic QC test records, equipment logs, other records, perform technical review of completed documents Equipment: lookout for failures/concerning trends; report problems; troubleshoot if possible Materials: Help receive deliveries; obtain documentation for raw material acceptance; perform in-house testing; coordinate 3rd party testing Help maintain backup supplies for QC: spare parts, consumables, PPE, other supplies Waste disposal and cleaning of QC lab Continuous Improvement: Embody and promote a culture of quality and continuous improvement Strive toward ambitious goals/timelines Draft/review SOPs and other documents Assist with Quality Events (deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, FMEAs, audits, inspections, investigations) Assist with repeating equipment qualification and/or method validation as needed This position may receive other responsibilities as needed

Orano Med, a subsidiary of the Orano Group, is a fast-growing clinical stage biotech company focusing on the development of targeted alpha therapy (TAT), an innovative class of pharmaceutical agents to combat cancer. Based on strong preclinical and clinical results, Orano Med is preparing for the commercialization of its products. Orano Med is looking for passionate employees willing to take responsibility and grow with the company.   Job Description: Orano Med is seeking a Computer Systems Validation Specialist to support implementing and managing electronic systems in a GMP environment ensuring compliance with FDA 21 CFR part 11/ Eudralex Electronic Records/Electronic Signatures regulation and 21 CFR/Annex 11 EU-GMP by identifying, validating and auditing electronic systems.   Major Duties and Responsibilities: Ensure regulatory compliance of electronic systems by: Developing CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Developing and maintaining test plans, test scripts and user acceptance tests and manage the execution of test plans Develop and maintain procedures related to Data Integrity and software validation, and lead 21 CFR Part 11 related training to all departments Identifying and qualifying all computer systems which impact cGMP operations using a risk-based methodology Working closely with Quality Assurance, Facilities and Engineering Teams to ensure appropriate validation of cGMP computer systems Lead the electronic systems implementation teams in the proper execution of validation documents Perform project management activities for CSV processes within the scope of an overall system project Execute or oversee the execution of validation plans and validation documents Act as the CSV Lead for all computer system validation projects, including spreadsheet and quality system validations Work with overall project manager to include validation activities in implementation timelines Evaluate proposed changes to validated computer systems and recommend level of revalidation activities required Review standards/regulation updates and perform gap assessments Coordinate and perform audits of internal computer systems, validation activities, protocols, and procedures, and prepare responses Lead corrective actions/preventative actions (CAPAs) pertaining to CSV Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies, and change control documents Maintain cGMP compliance and serve as the subject matter expert during regulatory audits Other duties as assigned (such as provide expertise on design of IS systems and drafting of USR) Remote position based in Brownsburg, IN, & initially 20% travel to Plano, TX

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