SummaryThis position is located in the Clinical Pharmacology Program (CPP), Office of the Clinical Director (OCD), Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS).
DutiesHelp
The incumbent serves as an analytical chemist supporting clinical pharmacology and translational drug-development research. The position develops, optimizes, validates, and applies quantitative bioanalytical methods to determine concentrations of drugs, metabolites, and related analytes in biological matrices, supporting pharmacokinetic and pharmacodynamic investigations and clinical study objectives.
- Develop, optimize, qualify, validate, transfer, and apply chromatographic and mass-spectrometric methods, particularly LC-MS/MS, for quantitative analysis of small-molecule drugs, metabolites, and selected peptides in biological specimens.
- Operate, maintain, and troubleshoot HPLC/UHPLC and tandem mass spectrometry systems; investigate sensitivity, selectivity, carryover, matrix effects, chromatographic interference, and analyte stability.
- Design and execute sample preparation procedures, including protein precipitation, liquid-liquid extraction, and solid-phase extraction; prepare calibrators, internal standards, blanks, and quality-control samples.
- Evaluate assay performance, including accuracy, precision, calibration range, lower limit of quantification, dilution integrity, selectivity, stability, and reproducibility; apply predefined acceptance criteria and document investigations.
- Acquire, process, critically review, and report quantitative data; contribute to pharmacokinetic data interpretation and coordination with clinical pharmacology investigators.
- Maintain traceable records, SOPs, method-validation protocols, sample-analysis reports, and quality documentation consistent with applicable FDA/EMA bioanalytical guidance, ICH M10, and laboratory quality practices.
- Coordinate specimen receipt, inventory, storage, transfers, and disposition; train laboratory personnel and communicate analytical findings to multidisciplinary study teams.
RequirementsHelp
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.
- Position has a pre-employment medical examination requirement.
- Position has an education requirement. Please submit transcripts.
QualificationsIn order to meet the Basic Qualification Requirements for a Chemist, GS-1320, you must have: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 to the Basic Qualification Requirements for a Chemist, GS-1320-12, you must meet the Additional Qualification Requirement listed below: You must demonstrate in your resume at least one (1) year of qualifying specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: 1) Developing or adapting quantitative chromatographic and mass-spectrometric methods for analysis of drugs, metabolites, or related compounds in biological matrices; 2) Performing LC-MS/MS quantitative analyses and independently evaluating calibration, quality-control, and sample results; 3) Identifying and resolving technical issues affecting analytical method performance or data reliability; and 4) Preparing technical documentation, such as SOPs, analytical method reports, validation records, or study data summaries.
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:EducationThis 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 a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
- A newly appointed or reappointed employee may receive service credit for prior work experience or active-duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
- 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 NIH maintains a tobacco free work environment and campus.
- Military Spouses selected from this announcement will remain in their current duty location (i.e., the official duty station of the military service member.
- 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 you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. If you meet the minimum qualifications of the position, after notification of the adjudication of your request, you will receive an email invitation to complete the USA Hire Competency Based Assessments, based on your adjudication decision. You must complete all assessments within 48 hours of receiving the URL to access the USA Hire Competency Based Assessments if you received the link after the close of the announcement. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation.
- 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.
BenefitsHelp
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.