Process Development Technical Professional

Location

Oak Ridge, TN | United States

Job description

Requisition Id 12666 

Overview:

As a U.S. Department of Energy (DOE) Office of Science national laboratory, Oak Ridge National Laboratory (ORNL) has an extraordinary 80-year history of solving the nation’s biggest problems. We have a dedicated and creative staff of over 6,000 people! Our vision for diversity, equity, inclusion, and accessibility (DEIA) is to cultivate an environment and practices that foster diversity in ideas and in the people across the organization, as well as to ensure ORNL is recognized as a workplace of choice. These elements are critical for enabling the execution of ORNL’s broader mission to accelerate scientific discoveries and their translation into energy, environment, and security solutions for the nation.

We are seeking a Technical Professional who will support the Medical Isotope Development (MID) Group in the Radioisotope Science and Technology Division (RSTD) of the Isotope Science and Engineering Directorate (ISED) in areas of radioisotope research, development, & demonstration (RD&D), maturation of R&D radioistopes to production, and production process improvement. This position will apply a graded approach to support and develop R&D work and quality control strategies, collaborate with scientists, technicians, and quality representatives and shepherd technologies through the maturization process.

The MID Group is comprised of R&D and technical staff that support the development and production of radioisotopes (such as, Ac-225 from Th-229, Accelerator-produced Ac-225, Ra-226, Ac-227/Th-227/Ra-223, Ac-227, Th-228, Ra-224/Pb-212 generators, W-188, Ni-63, and many others). Staff perform R&D on novel radioisotope production, separations technologies, maturation of R&D radioisotopes to production and continuous improvement on active ORNL production lines using radiochemistry facility equipped with radiological fume hoods, gloveboxes, and hot cells, and an array of radioanalytical instruments for the detection of alpha-, beta-, and gamma-emitting radioisotopes and quantification of radioactive samples. The team collaborates internally with other ORNL groups and externally with universities and research centers to enhance domestic production and utilization of radionuclides.

Major Duties/Responsibilities:

• Develop indepth understanding of radioisotope production processes.
• Work closely with technicians, quality representatives, engineers, and scientists to understand manufacturing issues and help provide solutions to mitigate them.
• Establish strategies for maturation of R&D radioisotopes and technologies.
• Provide robust technical support and guidance to facilitate the successful technology transfer from R&D to manufacturing.
• Lead validation and qualification efforts of newly developed processes as they are deployed from this role.
• Deliver tactical approaches for the implementation of robust processes tailored to individual processing finishing and dispensing product lines.
• Identification of critical process components and the development of graded science-based control strategy facilitating a robust and effective process.
• Provide risk based, graded, and strategically deployed processes for radioisotope processing.
• Review of post deployment change controls, validations/qualifications, and other such activities to ensure that the controls and intended operational standards remain intact.
• Develop detailed standard operating procedures (SOPs) that underpin manufacturing processes, ensuring procedural clarity and alignment with industry standards.
• Drive continuous improvement initiatives to enhance operational efficiency within manufacturing processes.
• Optimize existing processes for efficiency, cost-effectiveness, and facilitation of scalability.
• Work closely with analytical teams to ensure robust methods for monitoring and analyzing nuclear materials and processes.
• Provide technical expertise in the implementation of analytical controls within the development process.
• Collaboration with regulatory affairs and RSTD Sr. QR for the development of processes which will be implemented and executed by project level staff.
• Collaboration with scientific staff and operations to develop informative, effective, and achievable approach to data analytics.
• Collaborate extensively with cross-functional teams to align processes with project goals and regulatory requirements.
• Participate in project planning and execution.
• Deliver ORNL’s mission by aligning behaviors, priorities, and interactions with our core values of Impact, Integrity, Teamwork, Safety, and Service. Promote diversity, equity, inclusion, and accessibility by fostering a respectful workplace – in how we treat one another, work together, and measure success.

Basic Qualifications:

• A B.S. degree in Radiochemistry, Chemistry, Biology or a related technical discipline with at least eight years experience. A comparable combination of education and experience will be considered.
• Experience in collecting and interpretting radioanalytical data.
• Strong computer and organizational skills with the ability to multitask.
• Excellent written and oral communications skills.
• Demonstrated ability to work and collaborate in multi-disciplinary teams.
• Motivated self-starter with the ability to work independently and to participate creatively in collaborative teams across the laboratory.
• Ability to function well in a fast-paced research environment, set priorities to accomplish multiple tasks within deadlines, and adapt to ever changing needs.
• Position requires attention to detail and the ability to work as a team player interacting with multiple internal and external sites and with a culturally diverse group.
• Able to adapt and build processes to accommodate evolving product base in a dynamic environment.
• Understanding of the ICH and cGMP requirements regarding API manufacturing.

Preferred Qualifications:

• Knowledge of Nuclear Quality Assurance-1 (NQA-1) and experience with radiopharmaceuticals in a regulatory capacity.
• Familiarity with cleanroom environments and operations.
• Strategic planning in the development of new processes.
• Strong oral and written communication skills.
• Strong organizational skills, attention to detail and adaptability.
• Proven ability to anticipate and negotiate challenges to achieve desired outcomes.
• Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
• Demonstrated experience in multi-disciplinary R&D.
• Experience working in a Current Good Manufacturing Practice (CGMP) environment.
• Contributions to radionuclide production and dispensing activities.
• Familiarity of radionuclide applications in nuclear medicine.
• Understanding of and experience in radionuclide production.
• Knowledge of material science/engineering.
• Proficient in designing and executing new experiments.

Special Requirements:

Export control, no clearance:

This position requires access to technology that is subject to export control requirements. Successful candidates must be qualified for such access without an export control license.

About the Isotope Science and Engineering Directorate (ISED):

Established in 2020, the ISED is strengthening ORNL’s leadership in isotope production and enrichment technology innovation. ISED is guiding the Lab's pursuit of the fundamental science and technology that broadens the application of isotopes for energy, environmental, medical, and national security purposes. These efforts are made possible through the High Flux Isotope Reactor, the Radiochemical Engineering Development Center, ORNL's other nuclear facilities, and an assemblage of world-leading scientists and engineers. Please visit for more information about ISED.

Benefits at ORNL:

ORNL offers competitive pay and benefits programs to attract and retain talented people. The laboratory offers many employee benefits, including medical and retirement plans and flexible work hours, to help you and your family live happy and healthy. Employee amenities such as on-site fitness, banking, and cafeteria facilities are also provided for convenience.

Other benefits include: Prescription Drug Plan, Dental Plan, Vision Plan, 401(k) Retirement Plan, Life Insurance, Pet Insurance, Generous Vacation and Holidays, Parental Leave, Legal Insurance with Identity Theft Protection, Employee Assistance Plan, Flexible Spending Accounts, Health Savings Accounts, Wellness Programs, Educational Assistance, Relocation Assistance, and Employee Discounts.

If you have difficulty using the online application system or need an accommodation to apply due to a disability, please email: [email protected].

This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.

We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.

If you have trouble applying for a position, please email [email protected].

ORNL is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply. UT-Battelle is an E-Verify employer.

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