Los Alamos National Laboratory Isotope Program cGMP Technical Project Manager (Technical Project Manager 2) in Los Alamos, New Mexico
What You Will Do
The Isotope Program (IP) in the Chemistry Division produces and purifies radionuclides for medical and industrial applications as well as for fundamental research. We are seeking a Technical Project Manager professional to lead the quality program followed during production of these isotopes, which includes isotopes produced under current Good Manufacturing Practice (cGMP) controls. Isotope products are offered for distribution through the DOE Isotope Program, and are produced following graded quality requirements to meet end user requirements. This individual will maintain and continue to improve the existing quality program to address emerging product lines and changing requirements.
The Technical Project Manager ensures that radioisotopes intended for use as Active Pharmaceutical Ingredients (APIs) are produced under appropriate controls and facility environments. New processing capability is being constructed for producing alpha-emitting therapy radioisotopes, and will provide input to ensure that facility and equipment designs are compliant with US Food & Drug Administration requirements and guidelines for API manufacturing. The successful candidate must understand radioactive decay and be able to enter work areas where radioactive materials are handled.
The successful candidate will …
Interpret quality assurance requirements provided in 21 CFR 211 and 21 CFR 212 and determine appropriate application in Isotope Program work procedures and documents
Review production batch files and perform final approval for release of radioisotope products for distribution (cGMP and non-cGMP products)
Review and approve analytical results of radioisotope products performed using standard methods including gamma spectroscopy and ICP-OES (inductively coupled plasma optical emission spectroscopy)
Assist in development of technical procedures and documents, and assess for implementation of QA requirements
Participate in the planning and design of new processing capability for alpha-emitting APIs to ensure compliance with 21 CFR 211
Lead cGMP training for the program
What You Need
Minimum Job Requirements:
Advanced knowledge of current Good Manufacturing Practice (cGMP) for drug manufacturing
Advanced knowledge of and experience with quality assurance activities including supporting regulatory, customer, and performance audits, recommending and implementing corrective actions, providing complete and accurate documentation of quality activities through technical reports, and ensuring quality assurance compliance
Working knowledge of and experience in project management of technical or operational work, including developing project plans, work breakdown structures, and work packages; managing to scope, schedule, budget, and technical baselines; and documenting baseline reports and change control actions.
Experience successfully collaborating with internal and external organizations
Experience with quality oversight of drug manufacturing (e.g., approval of production records or shop travelers, process validation, etc.)
Experience with quality related aspects of analytical methods including gamma spectroscopy, inductively coupled plasma spectroscopy or similar analytical techniques
Demonstrated experience in providing quality support to a technical organization
Ability to meet deliverables in a fast paced and dynamic team environment.
Must submit curriculum vitae (CV) and a comprehensive cover letter that addresses the job requirements listed above and outlines your vision for this position.
Education/Experience: Position requires a Bachelor’s Degree in Engineering, Quality Assurance, or Industrial Systems Engineering or a related field and 5 years of related experience; or, an equivalent combination of education and experience directly related to the occupation.
Experience with radioisotope production
Experience with new facility design and environmental controls for manufacturing
Experience with radioactive decay calculations
Work Environment: working alone, working overtime or irregular schedule, working near sources of ionizing radiation
Note to Applicants: For full consideration, applicants must submit curriculum vitae (CV) and a comprehensive cover letter that addresses the job requirements listed above and outlines your vision for this position.
Location: This position will be physically located in Los Alamos, New Mexico.
Position commitment: Regular appointment employees are required to serve a period of continuous service in their current position in order to be eligible to apply for posted jobs throughout the Laboratory. If an employee has not served the time required, they may only apply for Laboratory jobs with the documented approval of their Division Leader. The position commitment for this position is 1 year.
Where You Will Work
Located in beautiful northern New Mexico, Los Alamos National Laboratory (LANL) is a multidisciplinary research institution engaged in strategic science on behalf of national security. Our generous benefits package includes:
PPO or High Deductible medical insurance with the same large nationwide network
Dental and vision insurance
Free basic life and disability insurance
Paid maternity and parental leave
Award-winning 401(k) (6% matching plus 3.5% annually)
Learning opportunities and tuition assistance
Flexible schedules and time off (paid sick, vacation, and holidays)
Onsite gyms and wellness programs
Extensive relocation packages (outside a 50 mile radius)
Northern New Mexico, Los Alamos National Laboratory is responsible for the safety, reliability and performance of the U.S. nuclear stockpile and for a wide variety of national security related research. In addition to its core missions, Los Alamos is world-renowned for research in a wide range of scientific disciplines, including chemistry, materials science, space science, geophysics, energy technologies, experimental, computational and theoretical physics, supercomputing, biosciences, nanotechnologies, and engineering technologies.
Chemistry Division (C) serves the Laboratory's core national security mission areas of weapons science and threat reduction with innovative chemical science and technology. Our capabilities are also essential for the emerging mission areas of energy security, civilian-sector R&D, and industrial partnering. Chemistry capabilities include analytical chemistry and measurement science; physical chemistry and molecular spectroscopy; isotope and actinide science; nuclear and radiochemistry; nanoscience; material processing and characterization; and chemical engineering.
Directive 206.2 - Employment with Triad requires a favorable decision by NNSA indicating employee is suitable under NNSA Supplemental Directive 206.2 . Please note that this requirement applies only to citizens of the United States. Foreign nationals are subject to a similar requirement under DOE Order 142.3A.
No Clearance: Position does not require a security clearance. Selected candidates will be subject to drug testing and other pre-employment background checks.
New-Employment Drug Test: The Laboratory requires successful applicants to complete a new-employment drug test and maintains a substance abuse policy that includes random drug testing.
Regular position: Term status Laboratory employees applying for regular-status positions are converted to regular status.
Internal Applicants: Regular appointment employees who have served the required period of continuous service in their current position are eligible to apply for posted jobs throughout the Laboratory. If an employee has not served the required period of continuous service, they may only apply for Laboratory jobs with the documented approval of their Division Leader. Please refer to PolicyPolicy P701for applicant eligibility requirements.
Equal Opportunity: Los Alamos National Laboratory is an equal opportunity employer and supports a diverse and inclusive workforce. All employment practices are based on qualification and merit, without regard to race, color, national origin, ancestry, religion, age, sex, gender identity, sexual orientation or preference, marital status or spousal affiliation, physical or mental disability, medical conditions, pregnancy, status as a protected veteran, genetic information, or citizenship within the limits imposed by federal laws and regulations. The Laboratory is also committed to making our workplace accessible to individuals with disabilities and will provide reasonable accommodations, upon request, for individuals to participate in the application and hiring process. To request such an accommodation, please send an email to email@example.com or call1-505-665-4444 option 1.
Contact Name Duran, Andria M
Vacancy Name: IRC85935
Organization Name C-DO/Chemistry
Minimum Salary 94100
Maximum Salary 155700
Req ID: IRC85935