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 Executive Director, Clinical Development will be responsible for providing clinical and scientific input into the development strategy for the clinical portfolio. In addition, the Dir., Clinical Development will provide medical oversight for ongoing clinical trials, including study document development (protocols, IBs etc.), overseeing outsourced medical monitoring, participating in internal clinical data reviews and assessments for safety reports. Job Duties: 1. Develop and support implementation of the clinical development strategy for the entire portfolio. In conjunction with program management, author clinical development plans. 2. Support interactions with health authorities by providing clinical and scientific expertise and input into drafting of various submissions  (INDs, annual reports, NDAs, inquiry responses etc). Attend meetings with health authorities as needed. 3. Provide medical oversight of ongoing clinical trials: a. Review, analyze and interpret safety information for clinical trials and provide recommendations based on emerging safety data where appropriate. b. Compile, analyze and present safety data analysis at (internal and/or external) safety review committee meetings. c. Maintain oversight of outsourced medical monitoring activities for quality and study plan and SOP compliance. d. Serve as medical resource for internal and external study teams to address medical / protocol related questions. e. Regularly attend study team meetings. f. Work with clinical team to ensure data collected are of high quality, including contributing to development of CRFs, edit checks and data review plans and regularly performs medical data review (including coding reviews). 4. May complete medical review including causality assessments for individual case safety reports and other safety/medical related regulatory documents. 5. Lead development of scientific publications, clinical trial design and protocols, investigator brochures and other study and/or asset level documents. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities. 6. Represent the company at scientific meetings, conferences and interactions with Key Opinion Leaders, Investigators, health authorities.

Orano Med is seeking a Sr. Analyst, QC or 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 Help recruit/train new employees 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 Location: On-site 100% This position may receive other responsibilities as needed.

General Summary: The Director of Clinical Supply will be responsible for overseeing the planning, coordination, and management of clinical trial materials and supplies. This role requires a strategic thinker with strong leadership skills, who can ensure the efficient and timely delivery of clinical supplies to support our clinical development programs. Job Duties and Responsibilities:  Strategic Planning and Management: Develop and implement clinical supply strategies to support clinical trial timelines and objectives. Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs and CMC, to ensure alignment on clinical supply needs and priorities. Oversee the demand forecasting and supply planning, for clinical trial drugs. Operationalization and Oversight: Manage the procurement, packaging, labeling, and distribution of clinical trial comparator products. Ensure compliance with all regulatory requirements and Good Manufacturing Practices (GMP) standards. Oversee the selection and management of third-party vendors and contract manufacturing organizations (CMOs) involved in the clinical supply chain. Create applicable trial documentation (e.g. pharmacy manual, labels) with input from relevant functions. Set-up and oversight of Interactive Response Technology (IRT) platforms used on clinical trials. Ensure timely and accurate financial reporting and forecasting related to clinical supplies. Quality and Compliance: Implement and maintain robust quality systems and processes to ensure the integrity and quality of clinical trial materials. Ensure compliance with all applicable regulatory guidelines, including FDA, EMA, and ICH guidelines. Lead the investigation and resolution of any quality issues related to clinical supplies.

Position Summary:  The Sr. Clinical Research Associate will oversee outsourced clinical operations activities including but not limited to site management, site monitoring and site level TMF filing. Additional responsibilities may be assigned (e.g. management of central labs). Job Duties: Oversee outsourced clinical trial monitoring by reviewing monitoring plans, monitoring visit reports, deviation listings, and conducting periodic oversight monitoring visits. Review site training materials including Site initiation visit slides and related materials.  May attend / present at site initiation visits (e.g. present company overview and pipeline slides). Develop or oversee development of study / country master ICFs; facilitating internal reviews as appropriate and applicable. Review subject facing documents (e.g. subject ID cards, subject instruction material) for accuracy against the protocol, IB, consent and other documents as applicable. Oversee site management activities by:Ensuring sites are compliant with GCP, and CROs are appropriate and timely escalation of deviations or non-compliance etc. Serve as primary point of contact for the CRO regarding site level issues. Review site level documents as relevant, e.g. site recruitment plans, site level ICF changes (including facilitation of internal review where appropriate). Ensuring timely collection /submission of updated regulatory documents and that TMF site files are in an inspection ready state. May also conduct or assist with study and country level TMF QC. Track distribution of safety letters to site. Escalate deviations from regulatory timelines to Clinical Project Manager. In coordination with other clinical team members, ensure study data quality by:Ensuring timely data entry and query resolution by sites. Serve as primary escalation point for late data entry / query resolution or lagging source data verification percentage. Support internal clinical data review process (e.g. review data for accurate subject disposition). Action follow-up items as applicable after internal data review meetings (e.g. schedule calls or follow-up with sites where additional discussion may be required). Provide updated site level documentation and applicable updates to regulatory as appropriate (e.g. updated 1572s, communicating site activations/site lists). Contribute to development of vendor oversight plans for outsourced clinical operations activities.

General Summary: The Sr. Manager of Clinical Quality will be responsible for building out and managing quality management infrastructure for the clinical development organization. The role will be responsible for leading process development, managing department training matrices, owning the CAPA and deviation process, coordinating contracted audits and driving inspection readiness activities. Job Duties and Responsibilities:  Provide oversight and management of the clinical quality management system including driving clinical process development and improvement, managing periodic review of department SOPs and department training matrices. Implement and manage the clinical process deviation and corrective and preventive action (CAPA) process. Implement periodic quality reviews with department leadership. Coordinate clinical QA audits including investigative site audits and service provider qualification audits. Maintain listing of audits conducted, obtain timely and adequate audit finding responses, scheduled requalification audits as appropriate. Maintain clinical quality related records (qualified service provider list, audit related documents). Oversee inspection readiness activities (set up of inspection hosting logistics, facilitating mock inspections, implementation of inspection related communication plans with external parties, driving storyboarding activities etc) and host / assist in hosting health authority GCP related inspections.

The Regulatory Specialist is responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable drug regulations, guidance, and standards (US/North America). Assist in creation and maintenance of regulatory files. Key Responsibilities: Write, analyze, and edit technical documents to support regulatory submissions and compile submissions, including IND and NDA submissions in the USA. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Maintain regulatory files. Maintain and update regulatory documents, such as INDs and NDAs. Assure that appropriate maintenance of registrations occurs including renewals, drug listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required. Assist in preparing responses to regulatory authorities’ questions within assigned timelines. Stay abreast of regulatory procedures and changes in regulatory climate. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. Perform as a member of the Change Control Board to identify regulatory impact and required regulatory reporting/submission for proposed changes. Other duties as assigned.

General Summary:   The Sr. Clinical Scientist will be responsible for designing clinical trials, contributing to data cleaning and analysis, contributing to regulatory submissions, collaborating with internal and external stakeholders, and providing scientific leadership.   Job Duties and Responsibilities:  Design clinical trials: Propose and ensure study designs are scientifically sound, feasible, and aligned with the clinical development strategy and any applicable regulatory requirements, advice and / or guidance. This includes defining eligibility criteria, selecting appropriate endpoints, and ensuring assessments are adequate to capture necessary data in support of endpoints. Author and/or contribute to clinical documents: Author clinical study protocols, contribute to clinical trial training materials (e.g Site Initiation Visit Slides), development of informed consent form and other patient materials, case report forms (CRFs) design, statistical analysis plans (SAPs) and clinical study reports (CSRs). Data Collection and analysis: Collaborate with clinical operations, biostatistics and data management teams to clean and analyze clinical trial data, interpret results, and prepare clinical study reports. Regulatory Submissions: Contribute to the preparation of regulatory documents, including Investigational New Drug (IND) applications, Investigator’s Brochures (IBs), and New Drug Applications (NDAs). Stakeholder Collaboration: Liaise with internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory authorities. Scientific Communication: May present clinical data and development plans to internal teams, external partners, and at scientific conferences. Medical Monitoring: May provide support for medical monitoring activities and/or serve as Medical Monitor for assigned trials.

General Summary: The Senior Manager of Safety Operations will oversee and manage the safety reporting operations in support of Orano Med clinical trials. This role ensures the accurate and timely collection, analysis, and reporting of safety data, in compliance with regulatory requirements and company policies. The ideal candidate will possess strong leadership skills, extensive knowledge of pharmacovigilance processes, and a deep understanding of clinical trial safety operations. Job Duties and Responsibilities:  Manage outsourced safety vendor(s) and processes to ensure compliance with contractual agreements and regulatory requirements. Ensure compliance with all relevant regulatory guidelines and requirements (e.g., FDA, EMA, ICH) related to clinical trial safety reporting including the accurate and timely entry of safety data into safety databases. Develop and track key performance indicators (KPIs) for the central safety vendor and clinical resource organizations (CROs) managing individual studies. Develop and maintain standard operating procedures (SOPs) and work instructions for oversight of outsourced safety operations. Put in place study level safety processes and safety reporting mechanisms (e.g. write safety management plans, oversee safety gateway set up and maintenance). Manage writing of safety reports, including periodic safety update reports (PSURs), Development Safety Update Reports (DSURs). Liaise with regulatory authorities regarding safety reporting and provide responses to safety-related inquiries. Lead initiatives to implement new technologies and tools to support safety data management and reporting. Stay current with industry trends, regulatory updates, and best practices in pharmacovigilance and safety operations.

Position Summary: This position will be responsible for overseeing the safety aspects of Orano Med clinical trials, ensuring patient safety, medical review of individual case safety reports, signal detection and contributing to authoring period reports and safety sections of relevant clinical documents. Job Duties and Responsibilities:  Oversee and manage the safety aspects of clinical trials and post-marketing surveillance. Ensure all safety activities comply with regulatory requirements and industry standards. Monitor and analyze safety data to detect safety signals and trends and take appropriate action. Prepare / review safety reports, including DSURs, PSURs, and other regulatory submissions. Provide medical review for individual case safety reports. Work closely with cross-functional teams, including clinical development, regulatory affairs, and pharmacovigilance, to ensure integrated safety management. Prepare consent form risk language, provide safety input into relevant clinical and regulatory documents (protocols, investigator brochures etc. Liaise with regulatory authorities, external safety committees, and other stakeholders regarding safety issues and updates.

Position Summary: The 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.

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.