Careers

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

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. 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: 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.

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 Project Manager (PM) works with members of the Global Development Team (GDT) to develop, track and report on cross-functional, integrated clinical development planning, timelines and risks. The role ensures that the program moves forward at the expected cadence and in accordance with company goals and is a key member of the GDT leadership team.  Job Responsibilities: Partner with Global Development Team (GDT) technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. Manage GDT meetings including developing agendas, documenting decisions and tracking/following up on action items. Ensure cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. Assist GDT technical leads with anticipating and tracking the execution of required deliverables and assists with navigating project teams through corporate governance. Build out project management tools to support internal program level anticipating, tracking and reporting. Capture project risks, develop mitigation plans and communicates project status clearly internally and externally as appliable. May include supervision of 1-2 junior project planners.

Position Summary: The Manager, Records Management or 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.

Orano Med is seeking an HR Generalist II-III for its Brownsburg, IN location. This position, under limited supervision, performs human resources activities and carries out responsibilities that are varied in nature, working in several HR functional areas for Orano Med Manufacturing in the US.  Major Duties and Responsibilities: The HR Generalist II-III will perform a variety of tasks including but not limited to: Serves as the primary HR contact for managers and employees in the guidance, interpretation and application of corporate policies and procedures. Propose and implement and best practices that support the mission of Orano Med. Works with Corporate HR regarding employee relations, investigation matters, strategic HR programs, and policies.  Provides day-to-day performance management guidance to line management (coaching, counseling, career development, disciplinary actions). Recruits, interviews and recommends placement of qualified candidates for administrative, professional, and/or technical staff positions from internal and external sources. Works with Corporate Compensation on all offers. Participates in interviews and provides counseling on all hiring decisions made in the respective business sector(s). Extends offers to selected candidates and may coordinate arrangements for relocation, as needed. Develops leadership that is accountable and focused employee engaged culture that emphasizes quality, continuous improvement and high performance as well as responsible succession planning. Works closely with management and employees to improve work relationships, build morale, increase productivity and retention. Work with Corporate HR and follow global guidelines to facilitate the Performance Development (PDA) process and the People Review Process in respective business sector(s). Additionally, participate in evaluation and monitoring of success of training programs. Follow-up to ensure training objectives are met. Provide guidance and input on workforce planning and succession planning. Represent the Company by responding to unemployment compensation claims and participating in hearings as needed. Actively engage outside resources in order to benchmark HR best practices in the external market. Liaise with Orano USA HR department to align policies and request assistance on expert matters.