Chemist (PET)

Summary

This position is located in the Positron Emission Tomography (PET) Department within the NIH Clinical Center and operates cyclotrons, hot cells, a cGMP manufacturing facility, and PET imaging scanners to support intramural clinical research. In this position, you will serve as a senior Chemist responsible for radiopharmaceutical production and analytical chemistry/quality control activities.

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Duties

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• Develops, validates, and optimizes automated radiosynthetic methods for PET radiopharmaceutical production.
• Establishes and maintains SOPs, batch records, specifications, and acceptance criteria in compliance with FDA regulations.
• Operates, monitors, and improves automated synthesis modules and radiopharmaceutical production systems.
• Coordinates production schedules with cyclotron, quality control, and clinical teams to ensure timely delivery.
• Investigates deviations and out-of-specification (OOS) results and implements corrective and preventive actions (CAPA).
• Performs analytical testing (e.g., HPLC, GC, TLC, UV-Vis, mass spectrometry) to assess identity, purity, and quality of products.
• Develops and validates analytical methods and ensures calibration and maintenance of laboratory instrumentation.
• Ensures compliance with CGMP and 21 CFR Part 11 requirements while maintaining complete and accurate documentation.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• This position has an Education Requirement. Please provide transcripts.
• Work in a laboratory environment involves the regular and recurring handling and exposure to radioactive materials and hazardous chemicals and requires strict adherence to radiation safety and PPE protocols.
• Requires training and validated competency in the safe use, storage, and disposal of high levels of radioactivity and use of protective laboratory coats, safety glasses and gloves.
• Requires some physical exertion such as extended periods of standing; bending, crouching, stooping, stretching, reaching, or similar activities, and may require recurring lifting of moderately heavy items like test equipment or boxes.

Qualifications

Basic Qualifications for the 1320 Chemistry Series: In order to qualify for a Chemist, GS-1320 position, you must have completed the requirements for a bachelor's or graduate or higher degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics OR a combination of education and experience course work equivalent to a major as shown above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

In addition, in order to qualify for a Chemist (PET) position at the GS-12 level, you must have 1 year of specialized experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: collaborating with multidisciplinary research teams to solve chemistry-related problems and improve scientific processes and laboratory procedures; performing routine and non-routine chemical analyses of drug, biological, environmental, or tissue samples; conducting equipment testing and supporting quality control procedures to ensure accuracy, reliability, and compliance with laboratory standards; supporting laboratory operations in a regulated environment by following established procedures and ensuring adherence to Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP) standards; and preparing, documenting, and communicating laboratory results to support research activities and regulatory requirements.

In addition, in order to qualify for a Chemist (PET) position at the GS-13 level, you must have 1 year of specialized experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: working with high levels of radionuclides, including the expert design and safe execution of radiolabeling experiments in support of chemical or radiochemical programs; calibrating, troubleshooting, and optimizing complex laboratory instrumentation (e.g., High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Thin-Layer Chromatography (TLC), Mass Spectrometry (MS)) to ensure data integrity and system performance; overseeing laboratory operations, including coordination of personnel, equipment, and workflows in a highly regulated environment; ensuring compliance with Good Manufacturing Practice (GMP)/Good Laboratory Practice (GLP) standards and applicable regulatory frameworks (e.g., FDA Investigative New Drug (IND) requirements); and reviewing, analyzing, and presenting radiochemical experimental data and laboratory reports to support scientific conclusions, operational decision-making, and continuous process improvement, particularly as it relates to PET drug production.

You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.

Do not copy and paste the duties or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer.

Preview application questionnaire before you apply: [click to reveal website link]https://apply.usastaffing.gov/ViewQuestionnaire/12943239

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Additional information

• This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
• Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
• PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
• The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
• The NIH maintains a tobacco free work environment and campus.
• Must be able to perform the essential duties of the position, with or without reasonable accommodation.
• Visit our Help Applying page for helpful information on the application process.
• If selected, you may be eligible to receive a salary above the minimum based on superior qualifications and/or a special need of the Government for your services. This applies to employees paid under the General Schedule (GS) and Federal Wage System (FWS) pay systems and is at the discretion of the hiring manager. A salary above the minimum must be approved before the appointment.

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

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Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.