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Pharmaceutical Scientist

Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
This job announcement has closed

Summary

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C.

Overview

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Reviewing applications
Open & closing dates
07/03/2025 to 07/14/2025
Salary
$120,579 to - $167,904 per year
Pay scale & grade
AD 00
Location
Many vacancies in the following location:
Silver Spring, MD
Remote job
No
Telework eligible
Yes—as determined by the agency policy.
Travel Required
25% or less - You may be expected to travel for this position.
Relocation expenses reimbursed
No
Appointment type
Permanent
Work schedule
Full-time
Service
Competitive
Promotion potential
00
Job family (Series)
Supervisory status
No
Security clearance
Other
Drug test
No
Position sensitivity and risk
Noncritical-Sensitive (NCS)/Moderate Risk
Trust determination process
Announcement number
FDA-CDER-25-T21-12758422-BD
Control number
840050700

This job is open to

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Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

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  • Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.
  • Evaluates the identification and characterization of drug substance's pharmaceutical properties and their impact on the drug products performance, manufacturing, and quality.
  • Assesses the choice of inactive ingredients (known as excipients) in a drug delivery system including its formulation and product design.
  • Applies a risk and scientific-based approach to evaluate the adequacy of formulation studies to understand the impact of drug substance and excipient attributes on drug product performance. Evaluates the adequacy of control strategy (including quality standards) for drug substance and excipients.
  • Establishes patient-centric quality standards for drug product to ensure its clinical performance. Evaluates the adequacy of the product usability and acceptability to the patient.
  • Evaluates the adequacy of analytical procedures and controls as well as associated sampling plans for quality testing, monitoring, and control. Evaluates the adequacy of procedures and data to ensure the stability of the drug product during its labeled shelf life and assess the adequacy of the container closure system and proposed storage conditions for the commercial drug product.
  • Evaluates manufacturing processes and facilities used by foreign and domestic manufacturers of drug products and assesses the adequacy of pharmaceutical manufacturing design and understanding, as well as process monitoring, control, and scale-up strategies.
  • Participates in facility inspections related to the evaluation of manufacturing processes and controls and in support of preapproval and current good manufacturing practices (CGMP) inspections.
  • Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes (e.g., heating, drying, milling, mixing, filtration, coating, filling, compaction, perfusion, and/or sterile production) through scientific or engineered approaches (e.g., design of experiments, modeling and simulations, or multivariate analysis).
  • Applies the scientific principles of International Conference on Harmonization (ICH) guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9), and Pharmaceutical Quality System (Q10) in the assessment of drug products, manufacturing, and control strategy, as well as in inspections, post-marketing, and surveillance activities.
  • Evaluates the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacturing, release and stability testing of drug substances and drug products.
  • Evaluates the adequacy of sponsors data and results, including drug substance and drug product manufacturing, in-process, release (including real time release testing when available) and stability data, using appropriate quantitative or mathematical approaches or tools.

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.
  • The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
  • Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
  • Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
  • One-year probationary period may be required.
  • Financial Disclosure may be required.
  • Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
  • Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.

Qualifications

In order to qualify for the Pharmaceutical Scientist position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025:

Basic Qualification Requirements: A bachelor's degree or higher in pharmaceutical science, pharmaceutical engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, biochemical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life sciences, engineering, mathematics, PharmD, biological sciences, agriculture, natural resource management. The degree must be from an accredited program or institution.

-OR-

Six (6) years of experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.

IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS.

1. Have a bachelor's degree and also have four (4) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.

2. Have a master's degree and also have three (3) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.

3. Have a Doctorate and/or J.D. degree and also have one (1) years of comparable experience involving work that requires reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing, biopharmaceutics, technical aspects of labeling, and environmental impact of pharmaceuticals. The work includes team-based evaluation and assessment of supplements through risk management practices.

4. Have a MD, DO, DDS, DPM, or DVM degree.


NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

  1. National Association of Credential Evaluation Services (NACES)
  2. Association of International Credentials Evaluators (AICE)
Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

Additional Conditions of Employment:

  • Pre-employment physical required: NO
  • Drug testing required: NO
  • License required: NO
  • Mobility agreement required: NO
  • Immunization required: NO
  • Bargaining Unit: YES, 3591.
  • Travel Required: YES, 25% or less.
  • Telework eligible position: Telework is at the discretion of the supervisor.
  • Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Additional Information:
  • Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
  • Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
  • If you are serving, or have served in the last 5 years (from 07/14/2025) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.
Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.
All requirements must be met by the closing date of this announcement (07/14/2025); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. You will be evaluated against the basic qualifications and if found qualified, you will be referred to the Hiring Manager for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.
Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

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