Careers

Position Summary The Intern – Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network. Safety and Compliance Read and follow all assigned relevant SOPs Safety: Reading/on-the-job training in radiation safety, hazardous materials, occupational safety. Assist with submissions and compliance for RAM license and environmental compliance. Production, QC, Shipping Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation. Observe and understand: function of all instrumentation; chemistry behind production of Pb-212 and radiolabeled final drug product; science behind all QC methods. Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc. Consumable supplies: assist with inventory management, including planning, purchasing, inspecting, and accepting incoming supplies. Assist with design and implementation of shipping equipment and procedures. Quality Assurance Embody and promote a culture of quality and continuous improvement. Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements. Learn about and gain comfort with cGMP and QMS. Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc. Project In consultation with the supervisor, the Intern is expected to identify and complete a project with reasonable scope during the period of the internship. Travel Amount: 1-3 optional travel opportunities The intern may receive other tasks and responsibilities as assigned.

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. ***Remote position in the U.S. 

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 Program & Project Management Leader (PPML) is a senior drug development leader with exceptional strategic and collaborative skills. This individual will directly lead one or more development program(s). In addition, this newly created role at Orano Med will also establish the key processes and tools in order to establish a fit for purpose function in order to support the rapid expansion of our pipeline of future cancer medicines based on our leading Pb212-based alpha therapy platform.   Primary Responsibilities: Acts as the cross-functional leader accountable for leading the design, approval and delivery of the integrated drug program strategy for our most advanced program, currently finishing phase 2. The role may also include future programs, from first-in-human study throughout the lifecycle, hence maximizing the value of the asset/program(s) or group of programs, consistent with the company strategy. Leads a high performing, cross-functional Global Development Team (GDT) composed of subject matter experts from the various functions contributing to the drug development process (research, translational, regulatory, clinical, manufacturing, medical affairs, IP, communication, quality, compliance and commercial). In addition, as some assets will be partnered with external collaborators, the PPML will have to collaborate with external parties, both biotech and larger pharmaceutical companies. Leads GDT meetings, ensure cross functional alignment, positive dynamics and productivity. Accountable to ensure there is a sound, competitive and compelling, asset strategy and execution plan to ultimately achieve global regulatory filings and ensure wide access of the compound. Accountable for the execution and delivery of strategic plans with speed, agility and high-quality. Ensuring that innovative as well as practical approaches are used to design development plans. Maintaining the highest degree of integrity and ethics, a drive for performance and differentiation. Managing development budget to ensure planning and spending is within approved budgets and consistent with established operating expense goals and in line with Orano Med processes. Providing proactively regular strategic and tactical status updates to management and governance on progress, risks, opportunities and challenges, and pertinent changes in the external environment Responsible for establishing this new role at Orano Med and creating core program management processes accordingly. Direct oversight for the project management function, also being newly established.

Orano Med is a leading innovator in the field of isotope and drug product manufacturing, dedicated to enhancing patient care through advanced therapeutic solutions. We are committed to excellence in our operations and are looking for a passionate and experienced Manufacturing, Science and Technology Specialist to join our team. The MS&T Specialist will assist in all technical aspects of isotope and drug product manufacturing. This role will contribute to the alignment among facilities, execute technical transfers to new manufacturing sites, train manufacturing teams, and implement new processes developed by R&D. The ideal candidate will possess a strong background in pharmaceutical manufacturing engineering and cross-functional collaboration. Primary Responsibilities Proactively works cross-functionally with teams such as R&D, quality, and safety to onboard new equipment and processes for manufacturing of radiopharmaceuticals. Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS. Writes documentation such as, but not limited to user requirement specifications, system classifications, risk assessments, IQ/OQ/PQs, operational SOPs, batch records, training OJT/OJQs, logbooks, etc. Develops and delivers phase appropriate product understanding and control strategies. Working with Supply Chain individuals, orders consumables and spare parts needed for equipment and processes. Assists with engineering/maintenance support. Supports manufacturing of radiopharmaceuticals throughout the product lifecycle. Demonstrates willingness to be flexible and adaptable to the needs of the department and business. Ensures internal/external sponsor expectations are met or exceeded. Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance reports. Ability to tech transfer equipment/processes to future facilities. Drives optimization of production efficiencies and capabilities by creating material workflows, room layouts, while also developing continuous process improvements. Performs other job-related duties as assigned.

Job Description Orano Med is seeking a Human Resources Intern for our office in Plano, TX. This temporary position within Orano Med provides support in functional areas of the Human Resources department, which may include recruiting, administrative support, and other projects.  Major Duties and Responsibilities Primary responsibilities and duties may include: Provide support for HR recruiting, including assisting with:maintaining recruiting system records and candidate files sourcing and outreach scheduling interviews reviewing and dispositioning applicants initiating the onboarding process Provide support to employees by answering incoming questions on various HR –related topics. Work on special projects as directed.

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.

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.

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.

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: 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.