Careers

Orano Med seeks to develop a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the most potent therapeutic payloads against cancer cells. Orano Med is a biotech company located in France and in the US (Plano, TX, and Brownsburg, IN). With several treatments currently at the clinical stage, Orano Med is a fast-growing R&D and industrial company. Orano Med LLC is currently looking for a Chief Accountant to manage and develop the Finance activities and support the growth of the US-based companies. This position reports directly to the CFO of Orano Med SAS located in France.  Job Responsibilities: Establish, implement, and maintain the financial plans and policies of the organization, including fiscal controls, preparation and interpretation of financial reports, statements, internal controls and safeguarding of the organization's assets. Ensure reports are reliable, delivered on time, and align with regional and global corporate requirements. Oversee cash collection and cash forecast processes. Work with the CFO of Orano Med SAS and department heads to develop and update annual budgets and coordinate financial planning. Review and analyze monthly trial balance to evaluate and manage risk and formulate sound financial strategies. Prepare monthly journal entries, reconcile all balance sheet accounts, and perform monthly closing of Orano Med and Macrocyclics books in NetSuite.  Review financials with department heads and senior management; publish financial statements for internal review. Prepare all relevant financial analysis to help decision-making. Hire, train, and manage finance team members. Work closely with Orano Med and Macrocyclics management teams to develop and document new processes that meet company needs and regulatory requirements.  Oversee accounts payable, ensuring that all vendor bills are paid on time. Prepare annual 1099s. Prepare accounts receivable invoices for Orano Med customers. Maintain accurate fixed assets subledger, reconcile CIP subledger to GL, place new assets into service, run monthly depreciation, update fixed assets module in NetSuite as necessary Oversee annual physical asset count. Work with Orano Med and Macrocyclics purchasing team as needed.  Prepare non-income tax declarations (monthly sales & use tax; annual real estate personal property tax). Work with outside tax team (Deloitte) regarding tax return filing and payment, and income tax provisions. Update Orano Med and Macrocyclics policies and procedures as needed to streamline operations and implement proper internal controls. Act as liaison between Orano Med and Orano USA regarding overlapping services and tasks.

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 seeking a GMP Equipment Technician I (Quality Technician I) performs installation qualification, maintenance, repairs, and project management of equipment and instrumentation in support of GMP manufacturing, GLP toxicity studies and QC testing operations. Supports daily operations by performing periodic & daily calibration of equipment. Major Duties and Responsibilities: The Equipment Technician will perform a variety of metrology and quality tasks including but not limited to: Perform daily calibration check of all production & laboratory equipment. Maintain equipment and water systems in accordance with written procedures. Utilize a wide variety of tools in performing repairs and maintenance of equipment. Schedule and accompany onsite calibration, qualification, and repair of equipment Perform internal calibration, qualification, and repairs. Send equipment for calibration or repair, as needed. Research/order new equipment and parts for repair of existing equipment. Execute Installation, Operation, and Performance Qualification protocols Perform Quality in-process checks and clearances  Assist QA with material release, document review/archival Assist QC with sample management, reagent preparations and testing.  Other quality related duties as needed.

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.

Position Summary: Orano Med is seeking a Manager, Facilities 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 safety, quality, volume, speed, and reliable supply. 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, 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

Position Summary: Orano Med is seeking a Senior Buyer (new job position) to oversee and manage all purchasing activities on a commercial scale for Orano Med LLC locations. Job Responsiblities: Operational Stage Ensure the correct realization of the Supply Chain objectives (planning, quality and costs) Manage the panel of local suppliers: Identify and propose new suppliers and manage relationships with local suppliers. Effectively communicate with Purchasing team, Departments, and external vendors (Supply Chain, Project Management). Bring expertise and support to the Project/Facilities Managers (supplier selection, correct execution of the contracts) Support all the functions within the purchasing process. Deliver reports to upper management Recommend updates for best practices. Resolve obstacles on the full Supply Chain Process (internally and externally) Negotiate with vendors on best offers and on contracts. Support the Purchasing Director:Identify local vendors Organize and structure within Purchasing department Annual Budget forecasting for Purchasing department. Scope of purchasing activities: equipment and services for all the facilities and the pharmaceutical activities in US. Management Stage Management of the Purchasing Performance on the scope of responsibilities Manage U.S. Purchasing team Manage the Supply Chain activities for the region (management of the call for tenders, negotiation with suppliers, contract negotiation and execution). Provide guidance and feedback to Purchasing team All Stages Location: On-site 70%, travel 30%