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Safety Officer
Regular/Permanent
USA / Texas
Published on 3/26/2024
Job reference : 2024-16266
The Safety Officer manages the Radiation Safety, Chemical Safety, and Environmental Health & Safety programs and serves as the subject matter expert for safety regulations impacting the various departments. Duties include developing policies and procedures in accordance with applicable regulatory entities.
Primary Job Duties:
Radiation Safety Officer
Formulates, prepares, and implements the Radiation Safety Policies and Procedures.
Implements the Radiation Worker Training program and provides Radiation protection oversight.
Trains employees on radiation safety procedures.
Reviews and maintains historical record of area surveys.
Tracks, trends and reports radiation exposure of employees and area radiation surveys.
Manages employee radiation exposure badges and electronic dosimeters
Maintains inventory of radioactive materials (RAM), RAM receipt documentation, RAM shipping documentation and usage logs.
Performs periodic equipment and sealed source checks to comply with applicable regulations.
Regularly inspects facility and audits practices for radiation safety compliance, addressing any concerns promptly.
Maintains DOT and Hazmat certification for compliance with radioactive material shipments – domestic and international.
Chemical Safety Officer
Formulates, prepares and implements the Chemical Hygiene Plan to ensure regulatory compliance as mandated by local, state, and federal agencies.
Formulates, prepares and implements chemical safety policies / programs such as proper chemical inventory, labeling & storage procedures, chemical material disposal, and chemical implications for fire protection.
Ensures proper chemical or hazmat spill preparedness & clean-up supplies are kept in stock.
Conducts routine and follow-up chemical safety and hazard inspections throughout the facility ensuring adherence to established procedures and proper operation of chemical hoods, eyewashes, safety showers and other emergency equipment.
Responds to emergency situations involving hazardous materials, or fire and smoke incidents; prepares reports of findings and submits recommendations.
Analyzes chemical accident and incident reports for trends; makes recommendations for correcting unsafe conditions and actions.
Environmental Health & Safety Officer
Develop, manage & maintain the Environmental Protection, Safety, and Health plan.
Perform process, jobs, and work site hazards analysis and reviews, and define the hazards controls to be integrated during planning activities, and implemented during process development, work instructions development, and work execution.
Monitor and evaluate activities and work areas, and address safety issues and concerns with employees; provide feedback into the work processes of issues observed.
Capture and report safety incident notifications, investigations, and the root cause.
Track and report company Safety Key Performance Indicators.
Maintain continuous improvement of the the Company's Safety Culture.
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Regulatory Specialist
Regular/Permanent
Canada / Saskatchewan
Published on 3/25/2024
Job reference : 2024-16237
· Support licensing and regulatory objectives, risks and challenges to ensure an integrated approach to the approval of projects and developments to maximize performance and minimize impacts to operational timelines
· Support, contribute and review the preparation and submission of regulatory documentation for life cycle mining, milling and project development including but not limited to environmental assessments and determinations, licensing requests, applications, notifications, along with their supporting documents and presentations to various regulatory bodies (both Provincial and Federal), including (but not limited to):
o Canadian Nuclear Safety Commission
o Saskatchewan Ministry of Environment
o Saskatchewan Energy and Resources
o Saskatchewan Labour Relations and Workplace Safety
o Environment and Climate Change Canada
o Transport Canada
· Interpret regulations, guidelines, communication materials and policies; assess impacts of new and future regulations; participate in internal and public reviews including regulatory change and compliance
· Work collaboratively with various technical specialists in the review of regulatory submissions including applications, notifications, amendments and licensing hearings
· Support the development and continual updating of the strategic planning document for regulatory actions, including the multi-year plan for Canadian Nuclear Safety Commission hearings/meetings. Assist with the identification of regulatory needs in the development of new or changing projects
· Participate in various internal and external working groups/committees, building relationships with interest groups/rights holders and fostering a collaborative spirit, ensuring stakeholders feel valued and included
· Support the Corporate Social Responsibility team in various community engagement activities – participating in meetings/events as required
· Assist with the identification of engagement needs related to the regulatory process of projects under review by regulators
· Support the development and implementation of regulatory aspects for the integrated management system within OCI
· Communicate effectively on regulatory topics to convey needs and expectations to a variety of stakeholder audiences
· Any other duties assigned by the Manager, Regulatory
Work location & schedule:
· Saskatoon Corporate Office with regular travel for short periods of time to operational or development sites as
well as travel for regulatory meetings (e.g., Ottawa, Regina, etc.)
Benefits and advantages of working with us:
· Competitive salary and benefits package
· A welcoming environment and great co-workers
· Training and development opportunities throughout your career
· Fitness equipment available for use on work/camp premises
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Buyer IV
Regular/Permanent
USA
Published on 3/25/2024
Job reference : 2023-14208
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.
This role can work out of our Plano, TX office or Brownsburg, IN office.
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%
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Mechanical CAD Technologist
Regular/Permanent
Canada
Published on 3/25/2024
Job reference : 2024-16236
Responsibilities include:
· Provide technical support with the preparation and updating of drawings and supporting documentation in all areas of an interdisciplinary engineering team
· Adhere to all company policies and procedures, engineering criteria, design standards and applicable regulatory codes. Take ownership of smaller projects and work independently with moderate supervision to meet deadlines and successful project completion
· Accurately analyse and measure as-built conditions and update drawings accordingly
· Contribute to updating and review of group procedures and work flows
· Research and respond to Requests for Information
· Technical Field coordination during construction activities
· Check drawings and review documents
· Provide mentorship as required
· Work in collaboration on various projects with other Departments (Operations, Maintenance, Safety, Radiation Protection, Services, etc) in the Orano organization
Work Location & Schedule:
· Based in the Saskatoon office
· Travel to Orano northern mine or project sites is required with varying durations and frequencies
Benefits and advantages of working with us:
· Competitive salary and benefits package
· A welcoming environment and great co-workers
· Training and development opportunities throughout your career
· Fitness equipment available for use on work/camp premises
· Career advancement opportunities, social committee, interesting projects and opportunities to get involved in our
strong commitments to communities
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Nuclear or Chemical Engineer III-V
Regular/Permanent
USA / North Carolina
Published on 3/21/2024
Job reference : 2024-16198
Orano Federal Services LLC combines the capabilities, technologies, and resources from multiple Orano companies to serve the United States Department of Energy, its subcontractors, and other clients in all phases of the nuclear fuel cycle. We provide know-how, key services, products, and technologies with high added value to our clients and their projects.
Orano Federal Services is seeking a Nuclear or Chemical Engineer to support safety analyses related to chemical separations processes and/or nuclear hazards analyses performed as part of its engineering division.
The Nuclear or Chemical Engineer will perform a variety of engineering tasks that may include but are not limited to:
Nuclear criticality safety evaluations and calculations
Radiological shielding evaluations and calculations.
Nuclear and chemical safety analyses such as HazOps, WhatIfs, FMEAs, Layers of Protection, etc.
Chemical reaction kinetics modeling and evaluations
chemical interaction matrices.
Development of NRC licensing support documents
materials evaluations (e.g., for compatibility).
Development of synergistic ideas applicable across multiple design disciplines.
Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Salary Range: $110-145k
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Process Expert
Regular/Permanent
USA / Indiana
Published on 2/29/2024
Job reference : 2024-15757
The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help cancer patients.
Primary Responsibilities:
Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records.
Collect data for process qualification and implementation.
Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
Support process optimization, development of new processes, and introduction of new technologies.
Lead equipment qualifications and improvement projects. Support the execution of process validations.
Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house.
Provide guidance, support, training, and knowledge to Production team.
Expanded Responsibilities:
Take a leadership role in managing multiple projects.
Work with other employees on the Production and Quality teams.
Coordinate internal resources and third parties.
Supervise work of contractors.
Create/maintain comprehensive project documentation. Work with Quality Unit to ensure readiness for inspections.
Ensure that all activities are in compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
Support cross-functional teams to address all site-related activities, such as urgent events that regulations, and Orano Med Policies.
Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.
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Senior Mechanical Engineer
Regular/Permanent
Canada / Saskatchewan
Published on 3/13/2024
Job reference : 2024-16087
Orano Canada is a leading producer in uranium in Canada, working to power the future with clean energy! Our McClean Lake mill is the most technologically-advanced mill in the world for the processing of high-grade uranium ore without dilution. Reporting to the Engineering Supervisor, in this role, you’ll be our lead technical mechanical engineer with the opportunity to work on a variety of interesting projects!
What you’ll be accomplishing:
· Perform conceptual and detailed mechanical/piping engineering design activities for both green field and brown field projects
· Support large multidisciplinary projects from conceptual to detailed engineering, continuing to construction and commissioning support as required
· Support the procurement process and preparing documents for the purchase of materials, and contracting engineering and construction services
· Prepare equipment specifications and procedures specific to the mechanical/piping discipline.
· Review the work of others meet applicable technical documents, regulatory requirements and QA/QC requirements specific to the mechanical/piping discipline.
· Provide mechanical technical support to other Orano Canada departments as required
· Supervise intermediate and junior engineers
· Other duties as requested by the Engineering Supervisor
Work location & schedule:
· Saskatoon corporate office
· Travel to Orano mine or project sites is required with varying frequency and duration (approximately 10%)
Benefits and advantages of working with us:
· Competitive salary and benefits package
· A welcoming environment and great co-workers
· Training and development opportunities throughout your career
· Fitness equipment available for use on work/camp premises
· Career advancement opportunities, social committee, interesting projects and opportunities to get involved in our strong commitments to communities
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Production Lead
Regular/Permanent
USA / Indiana
Published on 3/17/2024
Job reference : 2024-16131
Orano Med is seeking a Production Lead to support the production of commercial radiopharmaceutical products at the ATLab Indianapolis site. Orano Med, a subsidiary of the Orano Group, is a fast-growing biotech company focusing on the development of targeted alpha therapy, an innovative class of pharmaceutical agents to combat cancer. Based on strong clinical results, Orano Med is preparing for commercialization by opening a new, state-of-the-art facility in Indiana, where Orano Med will manufacture therapeutic radiopharmaceuticals from its drug pipeline. Orano Med is looking for people passionate about fighting cancer to join our team!
Reporting to the Senior Production Manager - Therapeutics, the Production Supervisor will assist in developing procedures for routine commercial manufacturing of Orano Med products. The Production Supervisor is responsible for managing production associates/activities, timely reporting of production deliverables, and timely implementation of the production schedule.
Primary Responsibilities
Managing production associates, including escalations to the Sr. Production Manager - Therapeutics
Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
Provide support to process experts / process owners including, SOP writing and revision, execution of qualification protocols, and batch records.
Daily / Weekly reporting of production activities and escalation of delays on the production floor.
Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
Support equipment qualifications and improvement projects.
Support the execution of process validations.
Provide guidance, support, training, and knowledge to Production team.
Expanded Responsibilities:
Take a leadership role in production team deliverables and projects
Work with other employees on the Production and Quality teams.
Work with Quality Unit to ensure readiness for inspections.
Maintain compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
Working as an active member of the production team on the floor, when needed.
Review and approval of production batch documentation.
Ensure Production teams cGMP and GDP training compliance, daily.
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Senior Specialist, Quality Assurance
Regular/Permanent
USA / Indiana
Published on 3/17/2024
Job reference : 2023-13106
Orano Med is seeking a Senior Specialist, Quality Assurance or Quality Assurance Specialist 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.
Setup Phase
Documents: Draft/review/approve SOPs, other QA documents (SVMP, QAAs, FMECA, Risk Analysis)
Review IQ/OQ/PQ for new cleanrooms, equipment, software
Tech transfer: PV runs, final report
Vendor qualification
Recruit employees
Relocate to the area by 2023-Q3; Travel <20%
Production Phase
Top Priority: Batch Release
Document Control: Release batch record/QC test records
Materials: Release from Controlled Storage
Manufacturing floor: maintain QA presence; process confirmation
Prompt review of documents for batch release
React to urgent problems
Operational line clearances/AQL inspections
Typical shift 3 PM-12 AM; OT, off-shifts if needed
QA Functions
Equipment: Review completed PM/RQ
Review GMP documents (records, equipment/service logs, certificates)
Expert on QMS: speak to management/inspectors
Materials: Inspect; Review COAs/acceptance sheets
Document Control
Qualify staff:
o Read & Understand
o Production: gowning, media fills, process
o Training matrix
Work 100% on-site; Travel <10%Continuous Improvement
Work with Production/QC/Shipping teams for mutual improvement
Internal audits, FMEAs
Oversee investigations to resolve equipment/process deviations/OOS/recalls/complaints
Coordinate CAPAs/Change Controls; effectiveness evaluation
Prioritize time in balancing production timelines with product quality assurances
Continue duties from Project Phase as needed
Leadership
Set tone in QA Team
Embody/promote culture of quality with continuous improvement
Example of determination, problem solving, servant leadership
Lead toward ambitious goals/timelines
Other duties as needed.
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Senior QC Analyst
Regular/Permanent
USA / Indiana
Published on 3/13/2024
Job reference : 2023-13919
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.
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Instrumentation Specialist, CQV
Regular/Permanent
USA / Indiana
Published on 3/13/2024
Job reference : 2024-16084
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.
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CNC Machinist, 2nd shift
Regular/Permanent
USA / North Carolina
Published on 3/12/2024
Job reference : 2024-16047
NO WAITING PERIOD ON BENEFITS! Rich benefit plan, effective date-of-hire. $2,000 signing bonus, paid after 60 days of employment.
Join our outstanding fabrication team in Orano’s state-of-the-art Kernersville facility! Embark on a career in supplying the nuclear industry with specialized products proudly made here in the heart of North Carolina!
Job Description
Orano is seeking an Experienced CNC Machinist to support the 2nd Shift machining performed in its nuclear fabrication facility in Kernersville, NC. This position offers top pay and outstanding benefits with no waiting period.
Major Duties and Responsibilities
Perform setup and operate CNC machining equipment per established methods/programs to consistently produce quality parts at productive rates.
May assist in developing conventional & CNC machining procedures & sequences, tools & fixtures.
Produce moderately complex to highly complex conventional machined components/tooling to precision tolerances.
Inspect work of other machinists and trains and assists lower classification machinists as directed by supervisor.
Comply with all plant work rules, regulations and specific instructions, and maintains required records, logs & documentation.
Identify & escalate operations problems to the area supervisor with objective options for resolution.
May assist engineering in developing methods, processes, and identifying tooling or equipment needed.
Exercise flexibility in work consistent with this work experience classification.
May develop cost estimates for machined and fabricated parts.
May develop conversational programming for CNC equipment and use of SMARTCAM or similar software.
Provide input to department supervisor for scheduling and resource allocation. Assist with training and operation of key equipment.
Play an active role in creating a safe and healthy workplace and comply with all applicable safety and health rules.
Orano strives to provide a total compensation package that brings value to our employees. While the pay range lists the base salary, we also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.
Please Note: The provided pay information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Pay Range: $26-$31/hour (plus 2nd Shift Differential of $2 per hour)
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Welder, 2nd shift
Regular/Permanent
USA / North Carolina
Published on 3/11/2024
Job reference : 2024-16036
NO WAITING PERIOD ON BENEFITS! Rich benefit plan, effective date-of-hire. $2,000 signing bonus, paid after 60 days of employment.
Join our outstanding fabrication team in Orano’s state-of-the-art Kernersville facility! Embark on a career in supplying the nuclear industry with specialized products proudly made here in the heart of North Carolina!
Job Description
Orano is seeking Experienced Welders to support the 2nd Shift work performed in its nuclear fabrication facility in Kernersville, NC. This position offers top pay and outstanding benefits with no waiting period.
Major Duties and Responsibilities
Weld components using GMAW (MIG) and GTAW (TIG) welding processes.
Perform fit-up as needing in fabrication process.
Work from travelers (shop routers), procedures, standards, and written and verbal instructions.
Maintain traceability of all materials and processes through established procedures.
Operate grinders and perform other shop fabrication tasks as needed.
Maintain clean and orderly work area.
Ensure proper functioning of equipment and maintain all tooling and equipment in accordance with standard shop practices.
Orano strives to provide a total compensation package that brings value to our employees. While the pay range lists the base salary, we also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.
Please Note: The provided pay information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Pay Range: $26-$31/hour (plus 2nd Shift Differential of $2 per hour)
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Senior Clinical Project Manager
Regular/Permanent
USA / Texas
Published on 2/23/2024
Job reference : 2024-15654
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 Senior Clinical Project Manager for its clinical trials.
The Senior Clinical Project 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 Senior Clinical Project Manager functions with minimal 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.
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Intern - Radiopharmaceutical Manufacturing
Student
USA / Indiana
Published on 3/8/2024
Job reference : 2024-15653
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.
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GMP Production Associate
Regular/Permanent
USA / Texas
Published on 3/1/2024
Job reference : 2024-15794
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 Production Associate.
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 Production Associate 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.
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General Maintenance Operator - Temporary - Talent Pool
Fixed term/Temporary
Canada / Saskatchewan
Published on 1/3/2024
Job reference : 2021-7509
Talent Pool - General Maintenance Operator positions
Join our talent pool for upcoming General Maintenance Operator positions. Submit your resume for future consideration when positions become available.
*Priority will be given to qualified Athabasca residents
Responsibilities include:
-Responsible for the safe and proficient operation of equipment associated with maintaining site services and miscellaneous earth-moving projects
-Operating various heavy duty equipment for earth-moving projects including haul truck, loader, excavator, and dozer
-Operating various light and medium duty equipment in the performance of general site services duties including gravel truck, vacuum truck, water truck, backhoe, bobcat, semi-tractor, forklift, grader, and bus
-Performing manual labour to support operations and maintenance activities, such as clean-up, hauling and stacking materials, and assisting skilled or semi-skilled crafts in the performance of their tasks
-Other duties and assignments as required by the Department and assigned by the Services Supervisor
-Embrace and support Operational Excellence efforts and OE Culture
-Comply with all Orano health, safety and environmental policies, practices and procedures
-Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
Work Location & Schedule:
-McClean Lake Mine site
-14 days in and 14 days out rotating schedule
-Normally an 11 hour work day, although some activity outside of normal working hours may be required
Fly Day - This position will fly in and fly out on Tuesday
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac and Wollaston.
As a condition of employment the successful candidate must complete Orano’s pre-employment checks including education verification and employment reference checks.
Drug (including marijuana) and alcohol substance testing is a requirement for all Safety Sensitive positions. Applicants who have recently used marijuana recreationally may not pass a substance test as marijuana can remain in the user’s system for as many as 30 days after use.
Orano is an equal opportunity employer. We value the knowledge, experience and cultures and commit to the advancement of Indigenous Peoples, Women, Visible Minorities and People with Disabilities and strongly encourage all candidates from these designated groups to apply for our career opportunities.
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Radiation Protection Technician - Temporary - Talent Pool
Fixed term/Temporary
Canada / Saskatchewan
Published on 1/3/2024
Job reference : 2023-13886
Join our talent pool for upcoming Radiation Protection Technician positions. Submit your resume for future consideration when positions become available.
*Priority will be given to qualified Athabasca residents
Responsibilities include:
· Carry out measurements prescribed in procedures and work instructions
· Record data collected as arranged
· Input data to appropriate databases or other records
· Carry out prescribed area, point and personnel monitoring, and develop required records
· Perform (or arrange for the performance of) calibration and maintenance of measuring devices and systems as prescribed
· Train/mentor employees as required by company programs
· Liaise with supervisors and workers in departments to ensure that actions in response to operational conditions are carried out as required
· Provide assistance and advice to employees on radiation and radiation protection related matters
· Comply with the Saskatchewan Occupational Health and Safety Act and Regulations, company health and safety policies, practices, and procedures, which apply to their work
· Embrace and support Operational Excellence efforts and OE Culture
· Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility.
Work Location & Schedule:
· McClean Lake Mine site
· Maximum 14 days in with at least equivalent time off (Normally 14 days in/14 days out rotating schedule)
· Normally an 11 hour work day, although some activity outside of normal working hours is frequently required
Fly Day- This position will fly in and fly out on Tuesdays
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
As a condition of employment the successful candidate must complete Orano’s pre-employment checks including education verification and employment reference checks.
Drug (including marijuana) and alcohol substance testing is a requirement for all Safety Sensitive positions. Applicants who have recently used marijuana recreationally may not pass a substance test as marijuana can remain in the user’s system for as many as 30 days after use.
Orano is an equal opportunity employer. We value the knowledge, experience and cultures and commit to the advancement of Indigenous Peoples, Women, Visible Minorities and People with Disabilities and strongly encourage all candidates from these designated groups to apply for our career opportunities.
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Warehouse Person - Temporary - Talent Pool
Fixed term/Temporary
Canada / Saskatchewan
Published on 1/3/2024
Job reference : 2023-12077
Warehouse Person - Temporary (Talent Pool)
Join our talent pool for upcoming Warehouse positions. Submit your resume for future consideration when positions become available.
*Priority will be given to qualified Athabasca residents
Responsibilities include:
- Issuing of material from inventory
- Handling/management and distribution of all materials for shipping and receiving- Customer Service
- Daily equipment checks and fuel checks
- Stock coding new items
- Proper placement of inventory and direct charge materials
- Physical inventory - cycle counts
- Keeping a clean work area
- Embrace and support Operational Excellence efforts and OE Culture
- Comply with all Orano health, safety and environmental policies, practices and procedures
- Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
Work Location & Schedule:
- McClean Lake
- 14 day in/ 14 day out rotating schedule
- Normally an 11 hour work day, although some activity outside of normal working hours may be required
- This position is physically demanding, must be able to lift up to 50 lbs.
- Ability to work rotating shifts (days and nights)
Fly Day- This position will fly in and fly out on Tuesday
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
As a condition of employment the successful candidate must complete Orano’s pre-employment checks including education verification and employment reference checks.
Drug (including marijuana) and alcohol substance testing is a requirement for all Safety Sensitive positions. Applicants who have recently used marijuana recreationally may not pass a substance test as marijuana can remain in the user’s system for as many as 30 days after use.
Orano is an equal opportunity employer. We value the knowledge, experience and cultures and commit to the advancement of Indigenous Peoples, Women, Visible Minorities and People with Disabilities and strongly encourage all candidates from these designated groups to apply for our career opportunities.
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Mill Operator - Temporary - Talent Pool
Fixed term/Temporary
Canada / Saskatchewan
Published on 1/3/2024
Job reference : 2021-7511
Mill Operator (Temporary) - Talent Pool
Join our talent pool for upcoming Mill Operator positions. Submit your resume for future consideration when positions become available.
*Priority will be given to qualified Athabasca residents
Responsibilities include:
-Conduct all duties required in a safe and efficient manner
-Successfully complete training in the following areas: confined space entry, fall protection, lockout, WHMIS, radiation
-Competently operate and troubleshoot independently once trained in an area
-Act as a peer trainer for the process areas once trained and competent in the six process areas
-Operate all mandatory mobile equipment competently
-Take on an active leadership roles (lead hand, project lead, new circuit commissioning, etc.…) when requested/required
-Actively participate in weekly safety huddles
-Main responsibilities include: Ore Receiving, Leaching, CCD/Tailings, Clarification/SX, Precip/Calcining, JEB and SUE Water Treatment and Central Control Room
-Embrace and support Operational Excellence efforts and OE Culture
-Comply with all Orano health, safety and environmental policies, practices and procedures
-Promote and adhere to Orano Canada’s values: Customer Satisfaction, Continuous Improvement, Respect and People Development, Cohesion and Team Spirit, and Exemplarity, Integrity, Responsibility
Work Conditions, Location & Schedule:
-McClean Lake site
-14 days in and 14 days out rotating schedule
-Normally an 11 hour work day, although some activity outside or normal working hours may be required
-This position is physically demanding
-May be required to lift moderately heavy objects (up to 50 pounds)
-Ability to work rotating shifts (days and nights)
Fly Day- This position will fly in and fly out on Tuesday
Pick-Up Points: Saskatoon, Prince Albert, La Ronge, Buffalo Narrows and the designated communities in the Athabasca region of Uranium City, Stony Rapids, Fond du Lac, and Wollaston.
As a condition of employment the successful candidate must complete Orano’s pre-employment checks including education verification and employment reference checks.
Drug (including marijuana) and alcohol substance testing is a requirement for all Safety Sensitive positions. Applicants who have recently used marijuana recreationally may not pass a substance test as marijuana can remain in the user’s system for as many as 30 days after use.
Orano is an equal opportunity employer. We value the knowledge, experience and cultures and commit to the advancement of Indigenous Peoples, Women, Visible Minorities and People with Disabilities and strongly encourage all candidates from these designated groups to apply for our career opportunities.